MedTrace Logo

A Study of the Use of PROCRIT (Epoetin Alfa) for the Treatment of Anemia in People With Chronic Kidney Disease Who Live in Long-term Care Facilities.

NCT00337935 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2013-05-13

Study results available
· View outcomes & findings →

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.

Conditions

  • Renal Failure , Chronic
  • Anemia

Interventions

DRUG

Epoetin Alfa

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

OTHER

Standard of care

Sponsors & Collaborators

  • Ortho Biotech Clinical Affairs, 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
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2009-07-31
Completion
2009-07-31

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 NCT00337935 on ClinicalTrials.gov