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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Meet the diagnostic criteria for chronic kidney disease, defined as a glomerular filtration rate (GFR) >=15 mL/min per 1.73 m2 and <60 mL/min per 1.73 m2 (Stages 3 and 4) as calculated by the central laboratory

• Hemoglobin level between 10.0 and 11.9 g/dL during the 4 weeks before randomization

• History of increase in hemoglobin after the initial dose

• Stable dose of epoetin alfa given once-weekly before randomization.

Exclusion Criteria:

• Uncontrolled hypertension

• Iron deficiency

• iron overload

• severe congestive heart failure

• Active infection

• Recent heart attack, Stroke or blood clot.