Anemia Clinical Trial
Official title:
A Phase 2, Open-Label, Multi-Center, Dose Finding Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Peginesatide for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated With Epoetin
The purpose of this study was to determine the dose ranges of peginesatide administered intravenously or subcutaneously that maintained hemoglobin in participants on dialysis whose hemoglobin values were stable on epoetin (alfa or beta).
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.
Six dose cohorts of 15 participants each were evaluated in this study. Participants received
peginesatide injection once every 4 weeks administered intravenously or subcutaneously for a
total of 7 doses.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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