Status:
COMPLETED
EPO-BUL-01 - Study of the Optimization of Anemia Management of EPREX (Epoetin Alfa) in Predialysis Patients With Chronic Renal Failure
Lead Sponsor:
Janssen Pharmaceutica N.V., Belgium
Conditions:
Chronic Renal Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to evaluate the effectiveness, safety and clinical outcome of Epoetin alfa with dosing regime in accordance with Summary of Product Characteristics in the treatment of anem...
Detailed Description
Open-label, non-randomized, multicenter study for anemic patients with hemoglobin \<or=11 g/dl. The dose of epoetin alfa is the routine dosage regimen and is in accordance of the approved SmPC. That's...
Eligibility Criteria
Inclusion
- Patients with Hb\<or= 11g/dl
- Females - using adequate contraceptive method
Exclusion
- Patients with uncontrolled or severe cardiovascular disease, including recent myocardial infarction, uncontrolled hypertension or congestive heart failure
- treatment within the previous 6 months with epoetin alfa or any erythropoietin, known hypersensitivity to the product or to any of the ingredients
- patient not in line with the approved SmPC
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
292 Patients enrolled
Trial Details
Trial ID
NCT00338000
Start Date
June 1 2001
End Date
May 1 2005
Last Update
February 1 2011
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