Anemia Clinical Trial
Official title:
A Phase 3b Single-Arm, Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis
The purpose of this study is to understand the effects of a dialysis center switching its dialysis patients from using Epoetin alfa to peginesatide injection on hemoglobin levels and other parameters.
Monthly Erythropoiesis-Stimulating Agents (ESA) dosing, compared with the longstanding
practice of dosing three times per week, represents a significant change in anemia treatment
for dialysis patients. Because of the differences in the processes needed to support monthly
dosing versus thrice weekly dosing, there is a need to prospectively identify and evaluate
factors in the dialysis environment during center-level transition of patients from one ESA
to another.
AFX01-18 is a Phase 3b open-label, single-arm conversion study that was conducted at 5
hemodialysis sites in the United States, and enrolled Chronic Kidney Disease (CKD) patients
receiving outpatient, in-center hemodialysis. The study treatment period was approximately
12 months in duration. Participants received peginesatide injection for approximately six
months.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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