Status:
TERMINATED
Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD (EU)
Lead Sponsor:
Affymax
Conditions:
Chronic Renal Failure
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Anemia associated with chronic kidney disease is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors inc...
Eligibility Criteria
Inclusion
- Participant is informed of the investigational nature of this study and has given written, informed consent in accordance with institutional, local, and national guidelines.
- Males or females ≥ 18 years of age.
- Premenopausal 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 grams per deciliter (g/dL) in the 4 weeks prior to study drug administration.
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00453973
Start Date
November 1 2006
End Date
September 1 2009
Last Update
June 29 2012
Active Locations (20)
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1
Research Facility
Burgas, Bulgaria, 8000
2
Research Facility
Pleven, Bulgaria, 5800
3
Research Facility
Plovdiv, Bulgaria, 4003
4
Research Facility
Rousse, Bulgaria, 7002