At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open Label, Multicenter Study of Epoetin Alfa Comparing Two Extended-Dosing Regimens, Once-Weekly and Every-Two-Weeks, With the Three-Times-Weekly Dosing Regimen for Initiation and Maintenance Treatment in Anemic Subjects With Chronic Kidney Disease
In Brief
A Phase 3 clinical trial evaluating Epoetin alfa 3 times weekly /once weekly, Epoetin alfa once weekly, and 1 other intervention for Anemia. Completed, enrolled 375 participants across 62 sites in 2 countries.
Detailed Summary
The purpose of this study is to demonstrate that once weekly and once every-2-weeks treatment with epoetin alfa, in patients with anemia associated with chronic kidney disease, is not less effective than the approved treatment with epoetin alfa that is given 3 times weekly with respect to changes in hemoglobin.
Study Details
Timeline
Interventions
Epoetin alfa will be administered as a SC injections at initial dose of 50 IU/kg (3 times weekly for 22 weeks) and at initial dose of 10000 IU (once weekly for 22 weeks)
Epoetin alfa will be administered as a SC injection at initial dose of 10000 IU (once weekly for 44 weeks).
Epoetin alfa will be administered as a SC injection at initial dose of 20000 IU (once every 2 weeks for 44 weeks).