Anemia Clinical Trial
Official title:
AFX01-12: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated With Epoetin Alfa
The purpose of the study was to evaluate the safety and efficacy of peginesatide in the maintenance treatment of anemia in participants on dialysis.
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 (ESAs) have been established as a treatment for anemia in
chronic renal failure subjects, and have improved the management of anemia over alternatives
such as transfusion. Peginesatide is a parenteral formulation developed for the treatment of
anemia in patients 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.
Eligible participants were randomized in a 2:1 ratio to peginesatide administered once every
4 weeks or to continued treatment with epoetin alfa administered 1-3 times each week,
respectively. Total commitment time for this study was 4 weeks of screening followed by a
minimum of 52 weeks of study treatment.
To evaluate the cardiovascular safety of peginesatide, a cardiovascular composite safety
endpoint (CSE) was defined for use in prospectively planned analyses which combined
cardiovascular safety data from the four Phase 3 peginesatide studies (NCT00598273,
NCT00597753, NCT00598442, and NCT00597584). The CSE consisted of six events: death, stroke,
myocardial infarction, and serious adverse events of congestive heart failure, unstable
angina, and arrhythmia. An independent Event Review Committee (ERC) was used to provide
blinded adjudication of potential CSE events.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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