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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 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 756 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01652872
The ClinicalTrials.gov registry entry for NCT01652872 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 756 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01652872 reports 0 study locations.
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.
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