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NCT01652872 · ClinicalTrials.gov registry record · Phase 3
Strategies Using Darbepoetin Alfa to Avoid Transfusions in Chronic Kidney Disease
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 756
- Enrollment target
NCT01652872: Completed Phase 3 study, sponsored by Amgen.
NCT01652872 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 756 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01652872, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 756 participants
- Enrollment target
Study Summary
A phase 3, multicenter, randomized, double-blind, parallel group study. Anemic subjects with chronic kidney disease (CKD) and not on dialysis will be randomized 1:1 to 1 of 2 dosing strategies to evaluate the proportion of subjects receiving at least one red blood cell (RBC) transfusion. In the haemoglobin (Hb)-based titration group, darbepoetin alfa doses will be titrated to maintain Hb ≥ 10.0 grams/deciliter (g/dL). In the fixed dose group, subjects will receive a fixed dose of darbepoetin alfa. Treatment group, darbepoetin alfa doses, and protocol specified Hb concentrations will be blinded. Subjects will be followed for approximately 2 years from the date of randomization.
Primary Outcome
The percentage of participants receiving at least 1 RBC transfusion during the evaluation period was recorded for each treatment group. The evaluation period began from the date of randomization, and participants were censored at the last dose of investigational product plus 3 months or end of study, whichever was earlier (on-treatment approach).
Interventions
- OTHER Placebo
- BIOLOGICAL Darbepoetin alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 756 participants |
| Start Date | 2012-07-30 |
| Est. Completion | 2017-10-19 |
| Phase | Phase 3 |
What the finished NCT01652872 record still lists
NCT01652872 is an interventional study that assigns participants to a tested intervention. The registered 756 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01652872 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01652872 about?
NCT01652872 is a clinical study titled "Strategies Using Darbepoetin Alfa to Avoid Transfusions in Chronic Kidney Disease". A phase 3, multicenter, randomized, double-blind, parallel group study. Anemic subjects with chronic kidney disease (CKD) and not on dialysis will be randomized 1:1 to 1 of 2 dosing strategies to evaluate the proportion of subjects receiving at least one red blood cell (RBC) transfusion. In the haem...
What is the current status of trial NCT01652872?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 756 participants. The study started on 2012-07-30. Estimated completion is 2017-10-19.
What interventions are being tested in trial NCT01652872?
The interventions under investigation include: Placebo (OTHER), Darbepoetin alfa (BIOLOGICAL).
Who is sponsoring clinical trial NCT01652872?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01652872's enrollment target sits among peer trials
756 457th of 2000 higher than 1,542 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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