CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 157 enrolled
Drug / intervention
Epoetin Alfa +1 moredrug
Likely dose
Epoetin Alfa 20,000 IUfrom 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/NCT00337935
NCT00337935Phase 2Completed
CompareCT.gov

An Open-Label, Randomized, Multi-center, Controlled Study of PROCRIT (Epoetin Alfa) for the Treatment of Anemia of Chronic Kidney Disease in the Long Term Care Setting

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Jun 20, 2006·Updated May 13, 2013

In Brief

A Phase 2 clinical trial evaluating Epoetin Alfa and Standard of care for Renal Failure , Chronic and Anemia. Completed, enrolled 157 participants.

Detailed Summary

The purpose of this study is to show that giving PROCRIT (Epoetin alfa) every 2 weeks to increase the hemoglobin (Hb) level and then to adjust the PROCRIT (Epoetin alfa) dose every 4 weeks (Q4W) to maintain Hb levels, is safe and effective in patients with anemia from Chronic Kidney Disease (CKD), not on dialysis, who reside in long-term care facilities. In this study the frequency of PROCRIT (Epoetin alfa) dosing is under investigation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Failure , Chronic, Anemia
Countries--
CollaboratorsOrtho Biotech Clinical Affairs, L.L.C.

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 20, 2006
Enrollment StartJul 1, 2006
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.0 years ago

Interventions

Epoetin Alfadrug

Epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks

Standard of careother