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PEARL 1: Peginesatide for Anemia in Chronic Renal Failure
NCT00598273Phase 3
Key facts
- Status
- Completed
- Start
- Oct 2007
- Primary completion
- Mar 2009
- Countries
- 2
- Sponsor
- Affymax, Inc.
- Modality
- Peptides, Polymer-based Nanoparticles
- Drugs
- peginesatide
- Conditions
- anemia
01
Overview
Phase 3, randomised, open-label trial of peginesatide in anemia (3 arms), sponsored by Affymax, Inc. Primary endpoint: Mean Change in Hemoglobin Between Baseline and the Evaluation Period. Started Oct 2007; status: completed.
02
Design
3 arms- Study design
- RandomizedOpen-label
Peginesatide 0.025 mg/kg
Peginesatide 0.025 mg/kg SC every 4 weeks
Peginesatide 0.04 mg/kg
Peginesatide 0.04 mg/kg SC every 4 weeks
Darbepoetin Alfa
Darbepoetin alfa 0.75 mcg/kg SC every 2 weeks
03
Who it enrols
Patients with chronic renal failure (eGFR < 60 mL/min/1.73m^2) not on dialysis and not treated with an ESA in the prior 12 weeks, with hemoglobin between 8.0 and 11.0 g/dL.
04
Endpoints
Primary
Mean Change in Hemoglobin Between Baseline and the Evaluation Period
Secondary
Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions
Proportion of Participants Achieving Hemoglobin Response
05
Results
Primary endpoints met
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