Status:
COMPLETED
An Efficacy and Safety Study of Epoetin Alfa for Initiation and Maintenance Treatment of Patients With Anemia Associated With Chronic Kidney Disease
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 t...
Detailed Description
This is a open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), multicenter study designed to show that 2 alternative dosing regimens,...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Uncontrolled hypertension
- Serum ferritin level less than 50 ng/mL
- Serum iron overload
- Severe congestive heart failure
- Active infection
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT00440557
Start Date
September 1 2006
End Date
February 1 2008
Last Update
May 7 2014
Active Locations (62)
Enter a location and click search to find clinical trials sorted by distance.
1
Glendale, Arizona, United States
2
Tempe, Arizona, United States
3
Chula Vista, California, United States
4
Long Beach, California, United States