Status:
COMPLETED
PROCRIT Extended Dosing For Maintenance of Hemoglobin in Pre-Dialysis CKD Patients
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Anemia
Renal Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 associa...
Detailed Description
A consequence of chronic kidney disease is anemia due to decreased production of erythropoietin. Anemia is associated with decreased oxygen delivery and utilization, and can result in fatigue, letharg...
Eligibility Criteria
Inclusion
- 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
- Uncontrolled hypertension
- Iron deficiency
- iron overload
- severe congestive heart failure
- Active infection
- Recent heart attack, Stroke or blood clot.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT00440466
Start Date
July 1 2007
End Date
March 1 2009
Last Update
April 21 2014
Active Locations (66)
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Chula Vista, California, United States
2
Fountain Valley, California, United States
3
Los Angeles, California, United States
4
Lynwood, California, United States