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

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 for the treatment of anemia in participants with chronic kidney disease, who are not on dialysis and not on erythropoiesis stimulating agent (ESA) treatment.

Key facts

Study ID

NCT00598442

Run by

Affymax

People needed

493

Starts

2007-11-01

Expected to finish

2009-12-01

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…

• Chronic renal failure with an estimated glomerular filtration rate < 60 milliliters per minute per 1.73 m\^2 and not expected to begin dialysis for at least 12 weeks.
• Two consecutive hemoglobin values ≥ 8.0 g/dL and < 11.0 g/dL within 4 weeks prior to randomization.

You may not qualify if…

• Females who are pregnant or breast-feeding.
• Treatment with an ESA in the 12 weeks prior to randomization.
• Known intolerance to any ESA, parenteral iron supplementation, or pegylated molecule.
• Prior chronic hemodialysis or chronic peritoneal dialysis treatment.
• 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
• A scheduled kidney transplant.

Where it is running

• Research Facility — Fayetteville, Arkansas, United States
• Research Facility — Fountain Valley, California, United States
• Research Facility — Fullerton, California, United States
• Research Facility — Granada Hills, California, United States
• Research Facility — Los Angeles, California, United States
• Research Facility — San Diego, California, United States
• Research Facility — Whittier, California, United States
• Research Facility — Lauderdale Lakes, Florida, United States
• Research Facility — Pembroke Pines, Florida, United States
• Research Facility — Pinecrest, Florida, United States
• Research Facility — Canton, Georgia, United States
• Research Facility — Columbus, Georgia, United States
• Research Facility — Marietta, Georgia, United States
• Research Facility — Caldwell, Idaho, United States
• Research Facility — Meridian, Idaho, United States
• Research Facility — Chicago, Illinois, United States
• Research Facility — Mishawaka, Indiana, United States
• Research Facility — Ames, Iowa, United States
• Research Facility — Baton Rouge, Louisiana, United States
• Research Facility — Lafayette, Louisiana, 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 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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