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

Key facts

Study ID

NCT00597584

Run by

Affymax

People needed

823

Starts

2007-10-01

Expected to finish

2010-01-01

Last updated by the study team

2013-03-08

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 IV epoetin alfa or beta 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 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 — Hot Springs, Arkansas, United States
• Research Facility — McGehee, Arkansas, United States
• Research Facility — Pine Bluff, Arkansas, United States
• Research Facility — Bakersfield, California, United States
• Research Facility — Glendale, 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 — Riverside, California, United States
• Research Facility — Simi Valley, California, United States
• Research Facility — Whittier, California, United States
• Research Facility — Yuba City, California, United States
• Research Facility — Westminster, Colorado, United States
• Research Facility — Lauderdale Lakes, Florida, United States
• Research Facility — Miami, Florida, United States
• Research Facility — Pinecrest, Florida, United States
• Research Facility — Flossmoor, Illinois, United States
• Research Facility — Hines, Illinois, United States
• Research Facility — Louisville, Kentucky, United States
• Research Facility — Rockville, Maryland, United States
• Research Facility — Springfield, Massachusetts, United States
• Research Facility — Detroit, Michigan, United States
• Research Facility — Detroit, Michigan, United States
• Research Facility — Brookhaven, Mississippi, United States
• Research Facility — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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