Anemia Clinical Trial
Official title:
AFX01-15: A Phase 2, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Correction of Anemia in Patients With Chronic Renal Failure (CRF) Undergoing Hemodialysis and Not on Erythropoiesis Stimulating Agent (ESA) Treatment
The purpose of this study is to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease who are on dialysis and are not taking any treatment to increase their red blood cell production.
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 equal proportions to two peginesatide treatment
regimens, in which participants received peginesatide once every 4 weeks, and one control,
epoetin alfa, treatment regimen, in which participants received epoetin alfa three times per
week. Total commitment time of this study was a 4 week screening period followed by a
minimum of 7 months of treatment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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