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

Launched by AFFYMAX · Mar 28, 2007

Keywords

ClinConnect Summary

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 include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. The presence and severity of anemia are related to the duration and extent of kidney failure. Anemia is associated with increased mortality, increased likelihood of hospitalization, reduced cognitive function, and increased left ventricular hypertrophy and heart failure.

Erythr...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 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