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PROCRIT Extended Dosing For Maintenance of Hemoglobin in Pre-Dialysis CKD Patients

NCT00440466 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2014-04-21

Study results available
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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

Conditions

Interventions

DRUG

epoetin alfa

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

DRUG

epoetin alfa

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

DRUG

epoetin alfa

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

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00440466 on ClinicalTrials.gov