Disease × agent evidence record

Darbepoetin Alfa for Chronic Kidney Disease: evidence, trials and status

Darbepoetin Alfa has both completed registered trials and synthesis-level publications linked to Chronic Kidney Disease. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit.

8 registered trials 0 recruiting 13 publications Evidence tier A · Strong Score 80.0
Research Tracker › Pairs › Chronic Kidney Disease › Darbepoetin Alfa
Research map, not treatment advice. This page aggregates registry and literature records. It does not evaluate efficacy, dosing or safety for any individual. Discuss any treatment decision with a qualified clinician.

Summary

Darbepoetin Alfa has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Chronic Kidney Disease would be drug repurposing rather than first-in-human development. This does not mean it is approved for Chronic Kidney Disease. ClinicalTrials.gov lists 8 registered trials linking Darbepoetin Alfa to Chronic Kidney Disease: 8 have completed. The most advanced is Phase 4 (NCT01506947). The largest enrolment is 1228 participants (NCT00090753). Registration activity spans 2004 to 2016. The literature layer holds 13 publications for this pair: 5 Cochrane reviews, 2 meta-analyses, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2014 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.

The RepurpOS disease-intelligence file for Chronic Kidney Disease ranks 534 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: GFR decline averages 2-5 mL/min/year on standard care (ACE/ARB + blood pressure control); progression to end-stage renal disease (ESRD) in ~20-30% at 10 years for moderate CKD; reversal essentially impossible once structural fibrosis established.

Open in Repurposing ExplorerChronic Kidney Disease hubChronic Kidney Disease biomarkers & interventionsChEMBLOpen Targets

Evidence table

Evidence tierA · Strong
Evidence score80.0 (trials 30.0, literature 30.0, tier 15, approved bonus 5.0)
Registered trials8 total: 0 recruiting, 0 active / not yet recruiting, 8 completed, 0 other
Linked publications13 (5 Cochrane reviews, 5 clinical trial publications, 2 meta-analyses, 1 randomised controlled trial publication)
Agent typeBiologic
Development stage (any indication)Approved
Mechanism / classNot recorded
Data sourcesOpen Targets, ChEMBL
How the evidence score is calculated
  • Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
  • Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
  • The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
  • Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
  • The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.

Registered clinical trials

NCT IDTitleStatusPhaseEnrolment
NCT01506947A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients
2012
completedPhase 465
NCT00090753A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia
2004
completedPhase 31,228
NCT00121602Efficacy Study: Darbepoetin Alfa for the Treatment of Anemia in Patients With Chronic Kidney Disease
2005
completedPhase 3446
NCT00598273Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis
2007
completedPhase 3490
NCT00112008Study for Subjects With Chronic Kidney Disease(CKD) Not Receiving Dialysis
2004
completedPhase 3100
NCT00661505A Study of Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia
2008
completedPhase 3132
NCT02912494A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)
2016
completedPhase 3—
NCT00526747Erythropoietin Resistance in Anemia of Chronic Kidney Disease
2007
completedNot applicable32

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Published literature

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Mechanism and notes

No mechanism of action is recorded for this pair in the source databases.

OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.

Frequently asked questions

Is Darbepoetin Alfa approved for Chronic Kidney Disease?

Darbepoetin Alfa has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Chronic Kidney Disease would be drug repurposing rather than first-in-human development. This does not mean it is approved for Chronic Kidney Disease. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.

Is Darbepoetin Alfa in clinical trials for Chronic Kidney Disease?

ClinicalTrials.gov lists 8 registered trials linking Darbepoetin Alfa to Chronic Kidney Disease: 8 have completed. The most advanced is Phase 4 (NCT01506947). The largest enrolment is 1228 participants (NCT00090753). Registration activity spans 2004 to 2016.

What does the evidence show for Darbepoetin Alfa in Chronic Kidney Disease?

Darbepoetin Alfa has both completed registered trials and synthesis-level publications linked to Chronic Kidney Disease. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.

Cite this page

Open Source Medicine Foundation. Darbepoetin Alfa for Chronic Kidney Disease: evidence, trials and status. OSMF Research Tracker. Updated 2026-07-05. https://research.opensourcemed.info/pairs/chronic-kidney-disease/darbepoetin-alfa.html

Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.

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This is a research map, not treatment advice. Evidence tiers and scores summarise what has been studied, not whether a treatment works or is safe for you.