Anemia Clinical Trial
Official title:
An Open-Label, Multi-Center, Extension Study to Evaluate the Safety and Tolerability of Peginesatide for the Long-Term Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease
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.
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.
Erythropoiesis stimulating agents have been established as a treatment for anemia in
subjects with chronic kidney disease, and have improved the management of anemia over
alternatives such as transfusion. Peginesatide is a parenteral formulation developed for the
treatment of anemia associated with chronic kidney disease. Peginesatide binds to and
activates the human erythropoietin receptor, and stimulates erythropoiesis in human red cell
precursors in a manner similar to other known erythropoiesis-stimulating agents (ESAs).
Study participants had received at least 24 weeks of peginesatide dosing in a previous
Affymax-sponsored study (NCT00228449) and were to receive doses of peginesatide for
approximately 54 months. However, the Sponsor ended the study early.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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