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Darbepoetin alfa

  • Biologic
  • Given by a clinician
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Darbepoetin alfa does in the body

Anemia due

From the FDA-approved label: Aranesp stimulates erythropoiesis by the same mechanism as endogenous erythropoietin.

What happened in people

RNAWiki has not yet published a reviewed conclusion for this use.

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

No reviewed claim names a result for any goal on this record.

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
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 · 15UQ94PT4P · read 2026-08-29

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

No statement of the main limit is recorded.

The four opening statements run to 29 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.

Placebo

A placebo is a dummy treatment given so the real one can be compared with it.

A picture of it, and where the picture fails

A placebo is like a blank control in an experiment.

Where that stops being true. A blank does nothing. People given a placebo often do get better.

What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.

An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.

Comparator

A comparator is whatever the treatment was measured against.

A picture of it, and where the picture fails

It is like the other runner in a race.

Where that stops being true. A race has one winner. A study can show both arms improved.

What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.

The control condition against which the experimental intervention is assessed.

What happened in peopleRead 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.

Primary Outcome of All-Cause Mortality

The study did not show it

Who was studied
NCT06660277
How many people
4800
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Time to All-cause Mortality or Cardiovascular (CV) Events Including Hospitalization Due to Acute Myocardial Ischemia, Congestive Heart Failure (CHF), Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)

The study did not show it

Who was studied
NCT00093015
How many people
4038
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period (Non-inferiority Analysis)

The study did not show it

Who was studied
NCT02876835
How many people
3872
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36)

The study did not show it

Who was studied
NCT02892149
How many people
3554
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period: Non-inferiority Analysis

The study did not show it

Who was studied
NCT02879305
How many people
2964
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Time to Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whichever Occurred First

The study did not show it

Who was studied
NCT00773513
How many people
2825
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 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 is missing or unclearRead 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.

  • Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis ( 1.1 ). The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy ( 1.2 ).

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: “Pediatric Patients with Cancer The safety and efficacy of Aranesp in pediatric patients with cancer have not been established.”

    US prescribing information · 0fd36cb9-c4f6-4167-93c9-8530865db3f9 · read 2026-08-30

  • On older people, the label states: “Of the 1801 patients with CKD in clinical studies of Aranesp, 44% were age 65 and over, while 17% were age 75 and over.”

    US prescribing information · 0fd36cb9-c4f6-4167-93c9-8530865db3f9 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary The limited available data on Aranesp use in pregnant women are insufficient to determine a drug-associated risk of major birth defects or miscarriage.”

    US prescribing information · 0fd36cb9-c4f6-4167-93c9-8530865db3f9 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of Aranesp in human milk, the effects on the breastfed child, or the effects on milk production.”

    US prescribing information · 0fd36cb9-c4f6-4167-93c9-8530865db3f9 · read 2026-08-30

Where the result stopped carrying

  • 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 takeRead 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 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.

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 (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. 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 takeRead 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

Subcutaneous

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

Sold as vial, solution, injection, solution, given by the subcutaneous, intravenous route.

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 takeNothing found in the sources checked

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.

Nothing found in the sources checked

No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.

The sources listed were searched and held nothing. That is not the same as nothing existing.

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 unclearRead 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

Subcutaneous

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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 14 products list this as an active ingredient in the United States drug directory. 14 of them contain it and nothing else.

    FDA National Drug Code directory · 55513-002 · read 2026-08-29

  • They are sold as injection, solution and solution, taken intravenous and subcutaneous.

    FDA National Drug Code directory · 55513-002 · read 2026-08-29

  • The regulator's established pharmacologic class for it is erythropoiesis-stimulating agent [epc], erythropoietin [cs] and increased erythroid cell production [pe].

    FDA National Drug Code directory · 55513-002 · read 2026-08-29

  • 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 · 0fd36cb9-c4f6-4167-93c9-8530865db3f9 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 0fd36cb9-c4f6-4167-93c9-8530865db3f9 · read 2026-08-29

  • 13 marketed supplement labels list this ingredient, classed as botanical, fat/fatty acid and other combinations.

    NIH Dietary Supplement Label Database · 206723 · read 2026-08-29

  • 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.

    NIH Dietary Supplement Label Database · 206723 · read 2026-08-29

  • ARANESP is intravenous at 3 DOSAGE FORMS AND STRENGTHS Aranesp is a clear, colorless solution available as: Single - dose vials Injection: 25 mcg, 40 mcg, 60 mcg, 100 mcg, and 200 mcg Single - dose prefilled syringes Injection: 10 mcg/0.4 mL, 25…, recorded as fda label in effect 2026-07-07 in the United States.

    US prescribing information · 0fd36cb9-c4f6-4167-93c9-8530865db3f9 · 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 takeRead 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 Darbepoetin 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 unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

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 Darbepoetin 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 peopleRead 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.

Where else this substance is registered

FDA substance identifier (UNII)
15UQ94PT4P
RxNorm concept
349273

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S6.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 1 approved application covers products containing this substance. The earliest was BLA103951, approved 20010917 to AMGEN.

    Drugs@FDA application register · BLA103951 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · BLA103951 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20060607.

    FDA National Drug Code directory · 55513-002 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

9 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.

  • What was measured, goal by goal — found nothing in the sources checked.
  • How close this is to real life — found nothing in the sources checked.
  • The path through the body — found nothing in the sources checked.
  • Felt, measured, or meaningful — found nothing in the sources checked.
  • 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.
  • Claims that go past the evidence — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

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.

Recorded evidence blocks (9)

On the Darbepoetin alfa label: indicated for what?


"Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis ( 1.1 ). The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of…": indications and usage on Darbepoetin alfa's label. DailyMed label · 0fd36cb9-c4f6-4167-93c9-8530865db3f9 · 2026-07-07

170 registered trials of Darbepoetin alfa — at which phases?


Registered studies posting no result
118 of 170

170 registered studies of Darbepoetin alfa: 78 phase3, 54 phase2, 21 phase4, 14 phase1, 7 na, 4 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01

231 with a PubMed record

Show the evidence
  • phase3
    78
  • phase2
    54
  • phase4
    21
  • phase1
    14
  • na
    7
  • na or unstated
    4
7 more recorded rows
  • completed
    140
  • terminated
    15
  • unknown
    5
  • not yet recruiting
    3
  • withdrawn
    3
  • active not recruiting
    2
  • recruiting
    2

recorded 2026-09-01 · last checked 2026-09-04

16 of Darbepoetin alfa's trials stopped: safety, accrual/recruitment, sponsor decision unspecified, other?


safety (3), accrual/recruitment (9), sponsor decision unspecified (1) and other (3): Darbepoetin alfa's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"The reason for the discontinuation of the study is difficulty with recruitment and timely enrolment and is not related to safety concerns"; 16 of 170 registered studies

Show the evidence

Trial

  • NCT00364845
    terminated; "The reason for the discontinuation of the study is difficulty with recruitment and timely enrolment and is not related to safety concerns"
  • NCT00381836
    terminated; "Terminated by sponsor due to general risk that aranesp caused tumor progression"
  • NCT00386152
    terminated; "No safety signals were noted. The study was stopped because it was no longer consistent with the company's scientific and strategic focus."
  • NCT00436748
    terminated; "FDA and EMA agreed that the information that had been submitted to date was acceptable to meet the requirements of the post-marketing commitment."
  • NCT00454246
    terminated; "Strategic decision unrelated to safety or efficacy"
  • NCT00534456
    terminated; "Study terminated"
10 further recorded trials
  • NCT00579046
    withdrawn; "no patient recruiting"
  • NCT00907608
    terminated; "Due to difficulty in patient recruitment"
  • NCT00989092
    terminated; "slow enrollment and change in product development strategy"
  • NCT01039350
    terminated; "It was stopped due to a lack of recruitment after 48 patients included"
  • NCT01197235
    terminated; "difficult to enroll targeted participants"
  • NCT01222195
    terminated; "Low accrual."
  • NCT01428154
    withdrawn; "Difficulty in recruitment. PDCO in the Day 30 summary report agrred to remove the PK study in children \<1 year of age."
  • NCT01890577
    terminated; "Study was terminated due to slow enrolment with no reasonable expectation of attaining a meaningful sample size"
  • NCT03242967
    withdrawn; "Revised study design."
  • NCT03446612
    terminated; "The study is terminated due to feasibility in recruitment."

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Darbepoetin alfa used Darbepoetin alfa - 2.25 mcg/kg — over how long?


studies of Darbepoetin alfa used the recorded amount. ClinicalTrials.gov · 2026-09-01

4 recorded entries; human; also "Darbepoetin alfa - 2.25 mcg/kg", "Darbepoetin alfa - 500mcg", "NESP 60μg"

Show the evidence

human

  • NCT00118638
    Darbepoetin alfa - 2.25 mcg/kg
  • NCT00118638
    Darbepoetin alfa - 500mcg
  • NCT01684605
    NESP 60μg
  • NCT03542916
    NESP 60ug

recorded 2026-09-01 · last checked 2026-09-04

Darbepoetin alfa's half-life is 1.4 hours — which schedules were studied?


1.4 hours, the half-life Darbepoetin alfa's label states: "Following intravenous administration of Aranesp to patients with CKD receiving dialysis, Aranesp serum concentration-time profiles were biphasic, with a distribution half-life of approximately 1.4 hours and a mean terminal half-life (t 1/2 ) of 21 hours." DailyMed label · 0fd36cb9-c4f6-4167-93c9-8530865db3f9 · 2026-07-07

bioavailability 37 %.

Show the evidence
  • half life pharmacokinetics
    1.4 hours; Following intravenous administration of Aranesp to patients with CKD receiving dialysis, Aranesp serum concentration-time profiles were biphasic, with a distribution half-life of approximately 1.4 hours and a mean terminal half-life (t 1/2 ) of 21 hours.
  • bioavailability pharmacokinetics
    37 %; The bioavailability of Aranesp in patients with CKD receiving dialysis after subcutaneous administration was 37% (range: 30% to 50%).

recorded 2026-07-07 · last checked 2026-09-04

Which 79 trials of Darbepoetin alfa posted no result?


Posted no result
79 of 79 completed trials
Registrations
NCT00526929, NCT03776032, NCT00119587, NCT00120705, NCT00540696 and NCT00527215, and 73 more
Completion dates
oldest 2002-02; newest 2023-08-28
Show the evidence

Trial

  • NCT00526929
    2002-02
  • NCT03776032
    2002-02-27
  • NCT00119587
    2003-09
  • NCT00120705
    2003-09
  • NCT00540696
    2003-09
  • NCT00527215
    2003-10
14 further recorded trials
  • NCT00117117
    2003-12
  • NCT00117624
    2003-12
  • NCT00120679
    2003-12
  • NCT00120692
    2003-12
  • NCT00121030
    2003-12
  • NCT00038064
    2004-04
  • NCT00111137
    2004-04
  • NCT00368901
    2004-05
  • NCT00369733
    2004-05
  • NCT00369772
    2004-05
  • NCT00117234
    2004-07
  • NCT00117247
    2004-07
  • NCT00527137
    2004-11
  • NCT00118638
    2005-01

At the median, Darbepoetin alfa's trials enrolled 150 people — anything larger?


Median enrolment
150
Largest enrolment
4038
Registered trials counted
154

What do 9298 spontaneous reports say about Darbepoetin 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.

Darbepoetin alfa appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 9298 reaction mentions were counted: hospitalisation 2943; haemoglobin decreased 1266; anaemia 1098; aplasia pure red cell 1026. FAERS via Open Targets · CHEMBL1201566 · 2026-06-24

Show the evidence
  • hospitalisation
    2943
  • haemoglobin decreased
    1266
  • anaemia
    1098
  • aplasia pure red cell
    1026
  • therapeutic response decreased
    902
  • haemodialysis
    797
4 more recorded rows
  • dialysis
    410
  • renal disorder
    324
  • haemoglobin abnormal
    275
  • nausea
    257

recorded 2026-06-24 · last checked 2026-09-04

Which 10 reactions does Darbepoetin alfa's label not list?


anaemia, aplasia pure red cell and dialysis and 7 more reported for Darbepoetin alfa, absent from its label. FAERS via Open Targets · CHEMBL1201566 · 2026-06-24

2 label terms; 10 reported and unlisted; 0fd36cb9-c4f6-4167-93c9-8530865db3f9

Show the evidence
  • anaemia
    count not stated
  • aplasia pure red cell
    count not stated
  • dialysis
    count not stated
  • haemodialysis
    count not stated
  • haemoglobin abnormal
    count not stated
  • haemoglobin decreased
    count not stated
4 more recorded rows
  • hospitalisation
    count not stated
  • nausea
    count not stated
  • renal disorder
    count not stated
  • therapeutic response decreased
    count not stated

recorded 2026-06-24 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1201566
CAS number
209810-58-2
RxCUI
283838
Trade name
Aranesp, Aranesp sureclick
Development code
DA-3880, KRN-321, KRN321, NESP
Also called
Da3880, Darbepoetin, Darbepoetina alfa, Darbepoetin alfa,recombinant, Darbepoetine alfa, Nespo, bcd-066, da, darbe, darbepoetin alpha, epo, epoetin
Sources (6)

Sources

ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 6 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

This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.