Overview

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

Status:
Terminated
Trial end date:
2009-11-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Affymax
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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