Safety & Efficacy of Peginesatide for Treatment of Anemia in Participants on Dialysis Not Receiving an ESA

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease who are on dialysis and are not taking any treatment to increase their red blood cell production.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Affymax
• Collaborator: Takeda
• Treatments: Epoetin Alfa; Hematinics

Criteria

Inclusion Criteria

1. On hemodialysis for chronic renal failure for at least 2 weeks prior to randomization.

2. Two consecutive hemoglobin values of ≥ 8.0 g/dL and < 11.0 g/dL within the 4 weeks prior to randomization.

Exclusion Criteria

1. Females who are pregnant or breast-feeding.

2. Prior treatment with an erythropoiesis stimulating agent (ESA) in the 12 weeks prior to randomization.

3. Known intolerance to any ESA, parenteral iron supplementation, or pegylated molecule.

4. Known bleeding or coagulation disorder.

5. Known hematologic disease or cause for anemia other than renal disease

6. Poorly controlled hypertension.

7. Evidence of active malignancy within one year.

8. A scheduled kidney transplant.