Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease, who are not on dialysis and not on erythropoiesis stimulating agent (ESA) treatment.

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

Details

• Lead Sponsor: Affymax
• Collaborator: Takeda
• Treatments: Darbepoetin alfa; Hematinics

Criteria

Inclusion Criteria:

1. Chronic renal failure with an estimated glomerular filtration rate < 60 milliliter per minute per 1.73m^2 and not expected to begin dialysis for at least 12 weeks.

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

Exclusion Criteria:

1. Females who are pregnant or breast-feeding.

2. Treatment with an ESA in the 12 weeks prior to randomization.

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

4. Prior chronic hemodialysis or chronic peritoneal dialysis treatment.

5. Known bleeding or coagulation disorder.

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

7. Poorly controlled hypertension

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

9. A scheduled kidney transplant