Overview

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.