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A Study of Four Dosing Regimens of PROCRIT (Epoetin Alfa) in Patients With Chronic Kidney Disease. Protocol Addendum: Extension Study of Maintenance Therapy of PROCRIT (Epoetin Alfa) in Patients With Chronic Kidney Disease.

NCT00212875 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2011-05-23

No results posted yet for this study

Summary

The primary objective of this study is to compare the change in hemoglobin (Hb) from study start to the end of the study between the every 2 week and the every 4 week dosing regimens in patients with anemia of chronic kidney disease (CKD) initiated on PROCRIT (epoetin alfa). Protocol Addendum: The primary objective of the open-label extension portion of this study is to evaluate if epoetin alfa 40,000 Units given under the skin every six weeks, can maintain hemoglobin within the range of 11-12 g/dL in patients with anemia of CKD.

Conditions

Interventions

DRUG

epoetin alfa

Sponsors & Collaborators

  • Centocor Ortho Biotech Services, L.L.C.

    collaborator INDUSTRY

  • 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
2005-09-30
Completion
2007-02-28

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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 NCT00212875 on ClinicalTrials.gov