This page shows what was measured, who it was measured in, and what that does not settle.
What Epoetin alfa does in the body
In kidney failure that hormone stops being made, so the marrow sits idle.
Your kidneys are the oxygen sensor for your blood. When oxygen runs low they release a hormone that tells the bone marrow to build more red cells. Epoetin alfa is a manufactured copy of that hormone, made in mammalian cells so it carries the right sugar chains to survive in the blood. It does not add red cells; it restarts the order to make them.
Why people take it. Low red blood cell count caused by kidney failure, HIV treatment or chemotherapy
What happened in people
12 of 12 transfusion-dependent dialysis patients became transfusion-independent in the 1987 first-in-human trial
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
That because low haemoglobin predicts bad outcomes, raising haemoglobin with a drug prevents them
Where it acts
Erythroid progenitor cells in the bone marrow
Kind of result
The kind of result is not recorded
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as protein.
FDA substance registry · 64FS3BFH5W · read 2026-08-29
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
The recorded use, written for a reader without medical training. Not signed off.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 104 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
Absolute difference
An absolute difference is how many more people in a hundred were affected.
A picture of it, and where the picture fails
It is like counting heads in two rooms of a hundred.
Where that stops being true. Heads are easy to count. Study results carry a margin of error too.
What people get wrong. It is confused with a percentage change, which can look far larger.
The arithmetic difference in event rates between arms.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
What happened in people◇Read from sources, not yet reviewed
What was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Energy
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
…Waiting for a reviewer1 registered symptom measure.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Focus
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
…Waiting for a reviewer1 registered performance measure of this kind.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Blood sugar
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
△Only a number moved1 registered test measure.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Energy
fatigue
Focus
cognitive function
Blood sugar
insulin sensitivity
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
∅ Nothing in the sources checked
No registered study lists a life outcome for this goal.
… Waiting for a reviewer
1 registered symptom measure.
— Not recorded
Harms were not a registered measure for this goal.
△ Only a number moved
1 registered test measure.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Time to death or first non-fatal myocardial infarction
✗ The study did not show it
Who was studied
Normal Hematocrit Trial (Besarab 1998; predates ClinicalTrials.gov registration)
How many people
1233
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Risk ratio 1.3 (95% CI 0.9-1.9); trial halted before the stopping boundary was crossed
Repeated elsewhere
Replicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. Dialysis adequacy declined and intravenous iron requirement rose in the normal-haematocrit group, both of which are downstream consequences rarely quoted with the mortality result.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous or subcutaneous injection, single-dose and multiple-dose vials
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. More patients in the normalisation arm required dialysis (127 versus 111, p = 0.03), a renal outcome that the cardiovascular framing of the trial did not foreground.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous or subcutaneous injection, single-dose and multiple-dose vials
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 4 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.8 registered measures of this kind. 3 written-up studies measured this and did not show a benefit.
■What a body can do day to dayEvidence recorded. Walking, dressing, breathing, recovering.1 registered measure of this kind.
■Measured performanceEvidence recorded. How much was lifted, how far was run, how fast.1 registered measure of this kind.
■Symptoms and quality of lifeEvidence recorded. Pain, tiredness, mood, sleep, as the person rated it.2 registered measures of this kind.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.6 registered measures of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
□Cells in a dishNo evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
Epoetin alfa
What a person takes: Intravenous or subcutaneous injection, single-dose and multiple-dose vials.
The measurement behind this step
Given intravenously during haemodialysis or subcutaneously in non-dialysis patients. Multiple-dose vials contain benzyl alcohol and are not for neonates, infants, pregnant women or nursing mothers.
Getting in
Injected into a vein or under the skin
It is given intravenously during dialysis or as a subcutaneous injection. It has to be injected because it is a protein and would be digested if swallowed.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Subcutaneous bioavailability is well below intravenous, but the slower absorption gives a longer effective exposure, which is why the subcutaneous route needs less total drug per week in most patients.
The molecule is coated in branched sugars ending in sialic acid. Without them the liver would clear it from the blood within minutes.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Three N-linked and one O-linked glycan carry terminal sialic acid residues that shield the underlying galactose from the hepatic asialoglycoprotein receptor. Sialylation is the single largest determinant of in vivo potency, which is why glycan mapping is a release assay rather than a characterisation nicety.
Binds erythroid progenitor cells in the bone marrow
In the marrow it finds immature red cell precursors and docks onto their surface receptors.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
One erythropoietin molecule binds a preformed EPOR homodimer through two asymmetric interfaces of very different affinity, reorienting the receptor chains rather than bringing them together from a distance.
The receptor turns on an internal switch that tells the immature cell not to die and to keep dividing.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Receptor reorientation trans-activates the associated JAK2 kinases, phosphorylating EPOR cytoplasmic tyrosines and recruiting STAT5, PI3K and RAS-MAPK. STAT5 drives BCL-XL transcription, which blocks apoptosis in colony-forming unit-erythroid and proerythroblast stages.
Cells that would have died instead mature into red cells. They need iron to do it, which is why iron runs out fast once this drug is started.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Rescued progenitors proceed through terminal erythroid differentiation, each requiring roughly 1 mg of iron per 1 mL of packed red cells produced. Functional iron deficiency is the commonest cause of apparent hyporesponsiveness.
Haemoglobin rises, and above about 11 g/dL so does risk
The blood count comes up over weeks. Past a point, pushing it further has been shown to cause more strokes, clots and deaths rather than fewer.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Reticulocytosis appears within days and haemoglobin rises over two to six weeks. Above roughly 11 g/dL the measured trade-off turns: increased blood viscosity, hypertension, vascular access thrombosis and, in cancer, possible direct EPOR-mediated effects on tumour tissue. The dose itself, independent of achieved haemoglobin, is an additional candidate mediator that no trial has cleanly separated.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 6 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
quality of life
fatigue
Measured
Things only a test, a scale or a device shows.
hemoglobin response rate
hemoglobin level
hemoglobin
hemoglobin between baseline and the evaluation period
insulin sensitivity
hemoglobin levels
Meaningful
Things that change how a life goes, not only a number.
progression free survival
progression free survival at 1 year
disease free survival
overall survival
overall progression free survival
disease specific survival
cognitive function
survival
organ sparing survival
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (23)
determination of safety profile and response rates
red blood cell transfusions
margin free resections produced by each program
clinical response
maximum tolerated dose of alemtuzumab
adverse events
myocardial infarct size
iron levels
efficacy
safety
sustained viral response
primary end
local control rate
left ventricular mass index
response
blood transfusions per visit
stem cell collection attempts
total number of days of stem cell collection
modified rankin
nihss response
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Adults and children on dialysis or with pre-dialysis chronic kidney disease, patients on myelosuppressive chemotherapy for non-curative cancer, patients on zidovudine, and some patients before major elective surgery.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “Safety and effectiveness in pediatric patients less than 1 month old have not been established [see Clinical Studies ( 14.1 )] .”
US prescribing information · 1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5 · read 2026-08-30
On older people, the label states: “Insufficient numbers of patients age 65 years or older were enrolled in clinical studies of Epogen for the treatment of patients treated with zidovudine for HIV infection to determine whether they respond differently from younger patients.”
US prescribing information · 1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Epogen from multiple-dose vials contains benzyl alcohol and is contraindicated in pregnant women [see Contraindications ( 4 )] .”
US prescribing information · 1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary Epogen from multiple-dose vials contains benzyl alcohol and is contraindicated in lactating women [see Contraindications ( 4 ) , Warnings and Precautions ( 5.9 ) ] .”
US prescribing information · 1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5 · read 2026-08-30
Where the result stopped carrying
Haemoglobin normalisation failed in dialysis (1998), in pre-dialysis chronic kidney disease twice (2006), and in cancer (2003, 2005)
The ESA APPRISE Oncology risk evaluation and mitigation strategy ran from 2010 until it was withdrawn in 2017
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
There was nothing to correct
Where a level is already normal, topping it up may change nothing.
On this record: US practice moved to the lowest dose that avoids transfusion, and biosimilar epoetin alfa-epbx was approved in May 2018
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (9)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Given by a clinician
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Intravenous or subcutaneous injection, single-dose and multiple-dose vials
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S6.
No source is stored against this line.
What is in the pack
Given intravenously during haemodialysis or subcutaneously in non-dialysis patients. Multiple-dose vials contain benzyl alcohol and are not for neonates, infants, pregnant women or nursing mothers.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take◇Read from sources, not yet reviewed
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
Boxed warning for death, myocardial infarction, stroke, venous thromboembolism, vascular access thrombosis and tumour progression or recurrence. Hypertension and seizures are labelled risks. Antibody-mediated pure red cell aplasia is rare but catastrophic, since the antibodies neutralise the patient own erythropoietin as well as the drug.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
These are reports people sent to a regulator. They do not show the medicine caused the reaction.
Nobody counted how many people took the medicine and reported nothing.
The same event can be reported more than once, and many reports are incomplete.
News coverage, lawsuits and new warnings change how often people report.
A count is not a rate and not a risk.
Epoetin alfa appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 3105 reaction mentions were counted. One report can name several reactions.
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Intravenous or subcutaneous injection, single-dose and multiple-dose vials
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Multiple-dose vials contain benzyl alcohol and are not for neonates, infants, pregnant women or nursing mothers.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on which forms are sold and how they compare.
No source is stored against this line.
What is recorded as being sold
1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5 · read 2026-08-29
13 marketed supplement labels list this ingredient, classed as botanical, fat/fatty acid and other combinations.
Those labels carry all other, nutrient and structure/function claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.
EPOGEN is intravenous at 3 DOSAGE FORMS AND STRENGTHS Injection: 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, and 10,000 Units/mL of Epogen as a clear and colorless liquid in single-dose vials. 20,000 Units/2 mL (10,000 Units/mL) and 20,000…, recorded as fda label in effect 2026-06-23 in the United States.
US prescribing information · 1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5 · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Epoetin alfa studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That because low haemoglobin predicts bad outcomes, raising haemoglobin with a drug prevents them
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That quality of life improves in proportion to achieved haemoglobin — CHOIR found no difference across a two-gram gap
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the harm is explained entirely by haemoglobin level rather than by ESA dose; no trial has separated the two
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
How fast does the body clear it?
The sources RNAWiki checked hold nothing for this field.
Why it matters. Without this, nothing on this page can say how long anything lasts.
What would answer it
A stored source that records it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Epoetin alfa are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Every line above can be traced to the study named beside it. Follow the link and read it.
1987: 12 of 12 transfusion-dependent dialysis patients stopped needing transfusions
In plain words
The first clinical trial was 25 patients. Everyone who received an effective dose responded, and the twelve who had been living on regular transfusions no longer needed them.
What was measured
12 of 12 previously transfusion-dependent patients became transfusion-independent
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Combined phase I and II trial, 25 anaemic haemodialysis patients, intravenous recombinant human erythropoietin three times weekly after dialysis at 15-500 units per kilogram. Dose-dependent increases in effective erythropoiesis. At 500 U/kg, haematocrit rose by as much as 10 percentage points within three weeks. Of 18 patients on effective doses, the 12 who had required transfusions no longer needed them and 11 reached a haematocrit of 35% or more. Four patients developed raised blood pressure. No anti-erythropoietin antibodies were detected.
Written into the record, not signed off as a reviewed claim
Normalising haematocrit was stopped early for harm, and the field reversed
In plain words
The obvious next step was to raise blood counts all the way to normal. A 1,233-patient trial in dialysis patients with heart disease was halted because more people in the normal-haematocrit group were dying.
What was measured
That because anaemia is associated with worse outcomes, correcting anaemia fully with an ESA improves outcomes
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The Normal Hematocrit Trial randomised 1,233 haemodialysis patients with congestive heart failure or ischaemic heart disease to epoetin targeting haematocrit 42% or 30%. After 29 months there were 183 deaths and 19 non-fatal myocardial infarctions in the normal-haematocrit group versus 150 deaths and 14 infarctions in the low-haematocrit group; risk ratio 1.3 (95% CI 0.9-1.9). The difference did not cross the prespecified stopping boundary, and the study was halted anyway. Patients in the normal-haematocrit group also had a decline in dialysis adequacy and needed more intravenous iron. The paper concluded that raising haematocrit to 42% is not recommended.
Written into the record, not signed off as a reviewed claim
CHOIR and CREATE confirmed it in pre-dialysis kidney disease, in the same month
In plain words
Two independent trials published side by side in 2006 tested the same idea in earlier kidney disease. Neither found a benefit, and one found clear harm.
What was measured
CHOIR composite hazard ratio 1.34 (95% CI 1.03-1.74), p = 0.03 for the higher haemoglobin target
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
CHOIR randomised 1,432 patients with chronic kidney disease to a haemoglobin target of 13.5 versus 11.3 g/dL. The composite of death, myocardial infarction, hospitalisation for congestive heart failure and stroke occurred in 125 versus 97 patients; hazard ratio 1.34 (95% CI 1.03-1.74), p = 0.03. Quality-of-life improvements were similar in both groups. CREATE randomised 603 patients with eGFR 15-35 to a normal (13.0-15.0 g/dL) or subnormal (10.5-11.5 g/dL) haemoglobin target; the primary cardiovascular composite showed hazard ratio 0.78 (95% CI 0.53-1.14, p = 0.20), left ventricular mass index did not change, and more patients in the normalisation arm required dialysis (127 versus 111, p = 0.03).
Written into the record, not signed off as a reviewed claim
In cancer, correcting anaemia shortened survival
In plain words
Two oncology trials designed to show that fixing anaemia helps cancer patients found the opposite: worse cancer control and worse survival in the treated arm.
What was measured
Pooled ESA mortality hazard ratio 1.10 (95% CI 1.01-1.20) across 13,611 patients
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The BEST trial randomised 939 women with metastatic breast cancer on first-line chemotherapy to epoetin alfa targeting haemoglobin 12-14 g/dL or placebo; it was stopped early by its data monitoring committee, and 12-month overall survival was 70% versus 76% (p = 0.01) against epoetin. The ENHANCE trial randomised 351 anaemic head and neck cancer patients undergoing curative radiotherapy to epoetin beta or placebo; locoregional progression-free survival was worse with epoetin, adjusted relative risk 1.62 (95% CI 1.22-2.14, p = 0.0008), and overall survival relative risk 1.39 (95% CI 1.05-1.84, p = 0.02). A pooled analysis of 51 trials and 13,611 patients found ESA mortality hazard ratio 1.10 (95% CI 1.01-1.20) and venous thromboembolism relative risk 1.57 (95% CI 1.31-1.87).
Written into the record, not signed off as a reviewed claim
The reversal is written into the label
In plain words
The current US prescribing information carries a boxed warning stating that no haemoglobin target, dose or dosing strategy has been found that avoids the increased risk.
What was measured
Label language: no haemoglobin target, ESA dose or dosing strategy has been identified that does not increase these risks
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The boxed warning states that in controlled trials patients with chronic kidney disease experienced greater risks for death, serious adverse cardiovascular reactions and stroke when ESAs were used to target a haemoglobin above 11 g/dL, and that no trial has identified a haemoglobin target, ESA dose or dosing strategy that does not increase these risks. For cancer it states that ESAs shortened overall survival or increased tumour progression in breast, non-small cell lung, head and neck, lymphoid and cervical cancers, and that ESAs are not indicated when the anticipated outcome is cure. From 2010 to 2017 dispensing was additionally controlled by the ESA APPRISE Oncology risk evaluation and mitigation strategy.
Source
EPOGEN US prescribing information, boxed warning
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
Quality of life was the justification, and it did not hold up
In plain words
Much of the case for pushing blood counts higher rested on patients feeling better. When trials measured that directly, the higher target did not deliver it.
What was measured
That higher haemoglobin produces proportionally better quality of life
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
CHOIR reported that improvements in quality of life were similar in the two groups despite a two-gram difference in achieved haemoglobin. CREATE did find significantly better general health and physical function scores in the normalisation arm, but against no cardiovascular benefit and more patients progressing to dialysis. The residual honest claim is that treating severe anaemia to the transfusion-avoidance range improves symptoms; the claim that more haemoglobin means proportionally more benefit is the one that failed.
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What is not here
4 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
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The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
A recombinant copy of the kidney hormone that orders red cell production; it reliably ends transfusion dependence in dialysis patients, and four large randomised trials then showed that pushing haemoglobin toward normal with it increases death, stroke and heart failure rather than reducing them.
Recorded evidence blocks (10)
Q2
What did Epoetin alfa's largest trial (2825 people) and its longest (23 years) measure?
2825 people in Epoetin alfa's largest registered study, 23 years in its longest registered window, measuring The primary outcome will be a composite consisting of mortality (all cause), myocardial infarction, stroke, and CHF hospitalization (not including those hospitalizations during which RRT occurs). ClinicalTrials.gov · 2026-09-01
105 phase2, 102 phase3, 46 phase4, 29 na, 27 phase1, 9 na or unstated, 1 early phase1; NCT00006436; 2024-01-18. Last human test completed 2024, NCT03079167.
Interpretation These counts include studies where Epoetin alfa was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase2
105
phase3
102
phase4
46
na
29
phase1
27
na or unstated
9
2 more recorded rows
early phase1
1
Last recorded human testNCT03079167
2024-04-30
recorded 2026-09-01 · last checked 2026-09-04
Q3
Epoetin alfa was tested only in human — what did it show?
Interpretation The primary outcome will be a composite consisting of mortality (all cause), myocardial infarction, stroke, and CHF hospitalization (not including those… — the recorded outcome words.
Show the evidence
humanNCT00211120
lifespan; The primary outcome will be a composite consisting of mortality (all cause), myocardial infarction, stroke, and CHF hospitalization (not including those hospitalizations during which RRT occurs); 306
"Per PI due to poor/inadequate accrual."; 51 of 306 registered studies
Show the evidence
Trial
NCT00005787
terminated; "Per PI due to poor/inadequate accrual."
NCT00017277
terminated; "low accrual"
NCT00083434
terminated; "This study was stopped because of an inadequate rate of enrollment."
NCT00104169
terminated; "No subject accrual"
NCT00210730
terminated; "This study was stopped early due to slow enrollment."
NCT00210795
terminated; "This study was stopped due to slow enrollment after enrolling only 12 of 80 patients over 14 months time."
14 further recorded trials
NCT00211120
terminated; "Stopped by the DSMB due to a trend toward more adverse events in the higher hemoglobin (Hb) arm and \<5% chance that the study would show benefit for higher Hb."
NCT00228995
terminated; "This study was stopped due to slow enrollment after enrolling only 9 of 80 patients over 14 months time."
NCT00236405
terminated; "The study was terminated due to poor enrollment."
NCT00236678
terminated; "This study was terminated due to slow enrollment, despite protocol amendments to change the entrance criteria."
NCT00240734
terminated; "This study was stopped for slow enrollment after enrolling only 11 of 180 patients in six months time."
NCT00246298
terminated; "OBI business decision not to complete any additional research in HIV."
NCT00246597
terminated; "Study stopped to avoid treating enrolled subjects to hemoglobin levels higher than those specified in current labeling."
NCT00306267
terminated; "Study stopped as it would not address important survival concerns raised in other recently conducted clinical studies."
NCT00310232
terminated; "Recommendation of DSMB for safety issue, increased mortality with study drug."
NCT00312871
terminated; "Study was stopped due to restrictions in labeling for the subcutaneous route of administration of EPREX."
NCT00319150
terminated; "New evidence and trouble recruiting"
NCT00338468
terminated; "The study was stopped early due to slow enrollment."
NCT00350090
terminated; "This study was stopped early due to slow enrollment."
NCT00350519
terminated; "The study was stopped due to slow enrollment"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Epoetin alfa used Eprex 40.000 IU — over how long?
5 recorded entries; human; also "Eprex 40.000 IU", "EPREX 40000 IU", "EPREX 10000 IU"
Show the evidence
human
NCT00631202
Eprex 40.000 IU
NCT01493973
EPREX 40000 IU
NCT01493973
EPREX 10000 IU
NCT02580006
EPREX INJ. 4000 IU (Erythropoietin alfa 4000 IU)
NCT03060603
Recombinant Human Erythropoietin, EPREX 4000 IU/0.4 ml
recorded 2026-09-01 · last checked 2026-09-04
Q6
Which of adverse events, blood transfusions per visit and clinical response did Epoetin alfa's trials measure?
adverse events, blood transfusions per visit and clinical response lead 40 outcome terms across Epoetin alfa's trials. ClinicalTrials.gov · 2026-09-01
progression free survival at 1 year, disease free survival, red blood cell transfusions, margin free resections produced by each program, clinical response and maximum tolerated dose of alemtuzumab follow.
Show the evidence
determination of safety profile and response rates
1
quality of life
1
progression free survival
1
progression free survival at 1 year
1
disease free survival
1
red blood cell transfusions
1
14 more recorded rows
margin free resections produced by each program
1
clinical response
1
maximum tolerated dose of alemtuzumab
1
adverse events
1
hemoglobin response rate
1
overall survival
1
overall progression free survival
1
myocardial infarct size
1
iron levels
1
efficacy
1
safety
1
sustained viral response
1
primary end
1
hemoglobin level
1
recorded 2026-09-01 · last checked 2026-09-04
Q7
Which of Epoetin alfa's 12 ongoing trials reports first?
Proportion of Patients With Major Erythroid Response (MER); Time to RBC transfusion dependence in non RBC transfusion dependent lower risk MDS patients with anemia with early (at inclusion of the patient) versus delayed onset,( at the…; latest 2033-10-01
Show the evidence
Trial
NCT00843882
"Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia"; n 247; "Proportion of Patients With Major Erythroid Response (MER)"; 2027-05-28
NCT03223961
"A Trial Testing Early vs Late Onset of EPO Alfa Treatment in Lower Risk MDS"; n 124; "Time to RBC transfusion dependence in non RBC transfusion dependent lower risk MDS patients with anemia with early (at inclusion of the patient) versus delayed onset,( at the threshold chosen for RBC transfusion) of EPO ALFA"; 2028-10-01
NCT03682536
"A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve"; n 363; "Percentage of Participants With Red Blood Cell Transfusion Independence (RBC-TI) for 12 Weeks (84 Days) With a Mean Hemoglobin Increase ≥ 1.5 g/dL"; 2027-09-28
NCT04588311
"ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients"; n 2500; "Combined proportion of participants who have died or have severe disability (WHODAS 2.0 > 25)"; 2027-08-31
NCT05181735
"Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESA"; n 150; "Part A : Dose-finding study"; 2029-06-19
NCT05564390
"MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)"; n 2000; "Timing of treatment Substudy or Tier Advancement Pathway (TAP) assignment"; 2029-05-15
6 further recorded trials
NCT05949684
"ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions"; n 402; "Number of participants with lower-risk non-transfusion dependent myelodysplastic syndromes (NTD-MDS) who converted to Transfusion Dependence (TD) during any continuous 16-week interval within the 96-week treatment period"; 2031-05-30
NCT06832189
"EVR and EPO for Liver Transplant Tolerance"; n 20; "The proportion of subjects free of opportunistic infection attributed to the investigational study regimen"; 2030-06-01
NCT06919861
"Pharmacokinetics, Pharmacodynamics, and Safety of NANOKINE Compared With Eprex 4000 U in Healthy Volunteers"; n 44; "AUC0-t"; 2027-06
NCT07422480
"A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions"; n 300; "Proportion of Participants who are RBC Transfusion Independent (RBC-TI) for any Consecutive Greater Than Equal to (≥) 12-Week Period From Day 1 Through 24 Weeks With Concurrent Mean Hemoglobin (Hgb) Increase ≥ 1.5 Grams per Deciliter…"; 2033-10-01
NCT07463820
"A Trial Comparing Three Different Treatment Options for Adults With Low-Risk Myelodysplasia and Anemia (A MyeloMATCH Treatment Trial)"; n 270; "Erythroid response rate"; 2027-12-31
NCT07755683
"Effect of Daprodustat and Epoetin Alpha on Anemia in Patients Not Undergoing Dialysis"; n 60; "Hemoglobin Levels"; 2027-02-28
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which 128 trials of Epoetin alfa posted no result?
Posted no result
128 of 128 completed trials
Registrations
NCT00270179, NCT00269945, NCT00270270, NCT00270010, NCT00270283 and NCT00266617, and 122 more
Completion dates
oldest 1988-05; newest 2024-04-30
Show the evidence
Trial
NCT00270179
1988-05
NCT00269945
1989-01
NCT00270270
1989-07
NCT00270010
1989-08
NCT00270283
1990-04
NCT00266617
1990-06
14 further recorded trials
NCT00269984
1990-06
NCT00269997
1990-07
NCT00270114
1991-03
NCT00270062
1991-07
NCT00270140
1991-08
NCT00270036
1991-10
NCT00270023
1991-11
NCT00269958
1991-12
NCT00270075
1992-05
NCT00270049
1994-01
NCT00270088
1994-08
NCT00270101
1996-09
NCT00322413
1997-04
NCT00270166
1998-05
Q9
At the median, Epoetin alfa's trials enrolled 80 people — anything larger?
Median enrolment
80
Largest enrolment
2825
Registered trials counted
291
Q10
What do 3105 spontaneous reports say about Epoetin alfa — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Epoetin alfa appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 3105 reaction mentions were counted: haemoglobin decreased 702; therapeutic response decreased 596; anaemia 574; aplasia pure red cell 459. open-targets-adr · CHEMBL1201565 · 2026-06-24
Show the evidence
haemoglobin decreased
702
therapeutic response decreased
596
anaemia
574
aplasia pure red cell
459
hospitalisation
249
haemoglobin abnormal
161
4 more recorded rows
anti-erythropoietin antibody positive
135
haematocrit decreased
91
myelodysplastic syndrome
76
transfusion
62
recorded 2026-06-24 · last checked 2026-09-04
Q11
Was Epoetin alfa studied with exercise?
exercise is named in Epoetin alfa's label sentences: "We hypothesized that treating anemia with subcutaneous epoetin alfa would be associated with reverse ventricular remodeling and improved exercise capacity and health status compared with placebo." openfda-label+europepmc · 2012-12-20
1 recorded statement; exercise
Show the evidence
exercise
We hypothesized that treating anemia with subcutaneous epoetin alfa would be associated with reverse ventricular remodeling and improved exercise capacity and health status compared with placebo.
recorded 2012-12-20 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 7 source rows
✓ no critical contamination: no quarantine open
✓ canonical metadata passed: slug and display name present
✓ no raw internal fields: enforced by the copy-contract test over the rendered page
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