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

Completed · Phase 3

Conditions studied: Anemia, Renal Diseases

In brief

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

Key facts

Study ID

NCT00440466

Run by

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

People needed

430

Starts

2007-07-01

Expected to finish

2009-03-01

Last updated by the study team

2014-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Uncontrolled hypertension
• Iron deficiency
• iron overload
• severe congestive heart failure
• Active infection
• Recent heart attack, Stroke or blood clot.

Where it is running

• Study site — Fountain Valley, California, United States
• Study site — Los Angeles, California, United States
• Study site — Lynwood, California, United States
• Study site — Orange, California, United States
• Study site — Riverside, California, United States
• Study site — San Dimas, California, United States
• Study site — West Hills, California, United States
• Study site — Yuba City, California, United States
• Study site — Lakewood, Colorado, United States
• Study site — Thornton, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Clearwater, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Plantation, Florida, United States
• Study site — Springhill, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Zephyrhills, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Augusta, Georgia, United States
• Study site — Macon, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Evergreen Park, Illinois, United States
• Study site — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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