Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD

Stopped early · Phase 2

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

In brief

The purpose of this study was to evaluate the long term safety and tolerability of peginesatide for the maintenance of hemoglobin in participants with chronic kidney disease (CKD) who had received at least 24 weeks of peginesatide treatment in an earlier study.

Key facts

Study ID

NCT00372489

Run by

Affymax

People needed

81

Starts

2006-09-01

Expected to finish

2009-11-01

Last updated by the study team

2012-06-29

Who can join

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

You may qualify if…

• Participant is informed of the investigational nature of this study and has given written, witnessed informed consent in accordance with institutional, local, and national guidelines
• Males or females ≥ 18 years of age. Pre-menopausal females (with the exception of those who are surgically sterile) must have a negative pregnancy test at screening; those who are sexually active must practice a highly effective method of birth control for at least 4 weeks prior to study drug administration, and must be willing to continue contraception until at least 4 weeks after the last dose of study drug.
• Participant who has received at least 24 weeks of peginesatide dosing in a previous Affymax-sponsored study
• One hemoglobin value of > 10.0 g/dL in the 4 weeks prior to study drug administration

You may not qualify if…

• Known intolerance to peginesatide or pegylated products
• History of antibodies to any erythropoiesis stimulating agent (ESA) or history of pure red cell aplasia (PRCA)
• High likelihood of early withdrawal or interruption of the study (e.g., participant suffers from any clinically significant medical disease or condition that may, in the Investigator's opinion, interfere with safety, assessment, or follow-up of the participant)
• Anticipated life expectancy < 18 months
• Receipt of any ESA other than peginesatide at any time after participant enrollment in the previous Affymax-sponsored study

Where it is running

• Research Facility — Pine Bluff, Arkansas, United States
• Research Facility — Mountain View, California, United States
• Research Facility — Lauderdale Lakes, Florida, United States
• Research Facility — Pembroke Pines, Florida, United States
• Research Facility — Shreveport, Louisiana, United States
• Research Facility — Detroit, Michigan, United States
• Research Facility — Canton, Ohio, United States
• Research Facility — Nashville, Tennessee, United States
• Research Facility — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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