CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 430 enrolled
Drug / intervention
epoetin alfa +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00440466
NCT00440466Phase 3Completed

A Randomized, Open-label, Multicenter Study of Epoetin Alfa Comparing Two Extended Dosing Regimens, Once-every-two-weeks and Once-every-four-weeks, With the Once-weekly Dosing Regimen for Maintenance Treatment in Anemic Subjects With Chronic Kidney Disease

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Feb 27, 2007·Updated Apr 21, 2014

In Brief

A Phase 3 clinical trial evaluating epoetin alfa for Anemia and Renal Diseases. Completed, enrolled 430 participants across 66 sites.

Detailed Summary

The purpose of this study is to demonstrate that once every-2-weeks and once every-4-weeks treatment with epoetin alfa, a drug that increases red blood cell production, in patients with anemia associated with chronic kidney disease, is not less effective than treatment with epoetin alfa that is given once a week

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 27, 2007
Enrollment StartJul 1, 2007
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 19.3 years ago

Interventions

epoetin alfadrug

Continue pre-study once weekly dose of epoetin alfa for 36 weeks

epoetin alfadrug

Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks

epoetin alfadrug

Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk