Strategies Using Darbepoetin Alfa to Avoid Transfusions in Chronic Kidney Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Anemia in Chronic Kidney Disease Patients Not on Dialysis

In brief

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.

Key facts

Study ID
NCT01652872
Run by
Amgen
People needed
756
Starts
2012-07-30
Expected to finish
2017-10-19
Last updated by the study team
2022-09-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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