An Efficacy and Safety Study of Epoetin Alfa for Initiation and Maintenance Treatment of Patients With Anemia Associated With Chronic Kidney Disease

Completed · Phase 3

Conditions studied: Anemia

In brief

The purpose of this study is to demonstrate that once weekly and once every-2-weeks treatment with epoetin alfa, in patients with anemia associated with chronic kidney disease, is not less effective than the approved treatment with epoetin alfa that is given 3 times weekly with respect to changes in hemoglobin.

Key facts

Study ID

NCT00440557

Run by

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

People needed

375

Starts

2006-09-01

Expected to finish

2008-02-01

Last updated by the study team

2014-05-07

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) more than or equal to 15 mL/min per 1.73 m2 and less than 60 mL/min per 1.73 m2 (Stages 3 and 4) as calculated by the central laboratory
• Require support of an erythropoietin receptor agonist

You may not qualify if…

• Uncontrolled hypertension
• Serum ferritin level less than 50 ng/mL
• Serum iron overload
• Severe congestive heart failure
• Active infection

Where it is running

• Study site — Tempe, Arizona, United States
• Study site — Chula Vista, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Lynwood, California, United States
• Study site — Riverside, California, United States
• Study site — San Diego, California, United States
• Study site — Visalia, California, United States
• Study site — Whittier, California, United States
• Study site — Yuba City, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Lakewood, Colorado, United States
• Study site — Thornton, Colorado, United States
• Study site — Lauderdale Lakes, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Palm Beach Gardens, 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 — Carrollton, Georgia, United States
• Study site — Macon, Georgia, United States
• Study site — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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