Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study was to evaluate the safety and efficacy of peginesatide in the maintenance treatment of anemia in participants on dialysis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria

1. Participants with chronic renal failure on hemodialysis for ≥ 3 months prior to randomization.

2. On intravenous epoetin alfa maintenance therapy continuously prescribed for a minimum of 8 weeks prior to randomization.

3. Four consecutive hemoglobin values with a mean ≥ 10.0 and ≤ 12.0 g/dL during the screening period

Exclusion Criteria

1. Females who are pregnant or breast-feeding.

2. Known intolerance to any erythropoiesis stimulating agent (ESA) or pegylated molecule or to all parenteral iron supplementation products.

3. Known bleeding or coagulation disorder.

4. Known hematologic disease or cause of anemia other than renal disease

5. Poorly controlled hypertension

6. Evidence of active malignancy within one year prior to randomization.

7. Temporary (untunneled) dialysis access catheter.

8. A scheduled kidney transplant

9. A scheduled surgery that may be expected to lead to significant blood loss.