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

Completed · Phase 3

Conditions studied: Chronic Renal Failure, Chronic Kidney Disease, Anemia

In brief

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

Key facts

Study ID

NCT00597753

Run by

Affymax

People needed

803

Starts

2007-09-01

Expected to finish

2010-01-01

Last updated by the study team

2013-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with chronic renal failure on hemodialysis for ≥ 3 months prior to randomization.
• On intravenous epoetin alfa maintenance therapy continuously prescribed for a minimum of 8 weeks prior to randomization.
• Four consecutive hemoglobin values with a mean ≥ 10.0 and ≤ 12.0 g/dL during the screening period

You may not qualify if…

• Females who are pregnant or breast-feeding.
• Known intolerance to any erythropoiesis stimulating agent (ESA) or pegylated molecule or to all parenteral iron supplementation products.
• Known bleeding or coagulation disorder.
• Known hematologic disease or cause of anemia other than renal disease
• Poorly controlled hypertension
• Evidence of active malignancy within one year prior to randomization.
• Temporary (untunneled) dialysis access catheter.
• A scheduled kidney transplant
• A scheduled surgery that may be expected to lead to significant blood loss.

Where it is running

• Research Facility — Fairfield, California, United States
• Research Facility — Granada Hills, California, United States
• Research Facility — Los Alamitos, California, United States
• Research Facility — Los Angeles, California, United States
• Research Facility — Los Angeles, California, United States
• Research Facility — Los Angeles, California, United States
• Research Facility — Lynwood, California, United States
• Research Facility — Monterey Park, California, United States
• Research Facility — Mountain View, California, United States
• Research Facility — Paramount, California, United States
• Research Facilities (2) — San Diego, California, United States
• Research Facility — San Dimas, California, United States
• Research Facility — Whittier, California, United States
• Research Facility — Denver, Colorado, United States
• Research Facility — Middlebury, Connecticut, United States
• Research Facility — Hudson, Florida, United States
• Research Facility — Ocala, Florida, United States
• Research Facility — Orlando, Florida, United States
• Research Facility — Orlando, Florida, United States
• Research Facility — Pembroke Pines, Florida, United States
• Research Facility — Augusta, Georgia, United States
• Research Facility — Augusta, Georgia, United States
• Research Facility — Decatur, Georgia, United States
• Research Facility — Marietta, Georgia, United States
• Research Facility — Paragould, Arkansas, United States

Full record on ClinicalTrials.gov

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