Status:
TERMINATED
Effects of Early Correction of Anemia in Patients With Chronic Renal Insufficiency
Lead Sponsor:
Janssen Cilag S.A.S.
Conditions:
Anemia
Renal Failure, Chronic Renal Failure
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The purpose of the study is to assess the effect of an early and complete correction of anemia after treatment with epoetin alfa on the rate of progression of chronic renal failure (which involves imp...
Detailed Description
Epoetin alfa can increase hemoglobin levels in chronic renal failure patients (patients with persistent kidney dysfunction) resulting in minimal transfusion requirements and improved kidney function c...
Eligibility Criteria
Inclusion
- Patients with a history of chronic renal failure, and at least a 6-month follow-up with at least 3 measurements of serum creatinine
- patients with a rate of decline in glomerular filtration rate (GFR--a measure of kidney function) below 0.6 mL/min/month
- patients with a hemoglobin level \<13 g/dL for men and \<12.5 g/dL for women without active blood loss or iron deficiency
- patients with a glomerular filtration rate (a measure of kidney function) between 25 and 60 mL/min/1.73m2)
- patients with blood pressure \<=160/100 mm Hg (with or without antihypertensive therapy)
Exclusion
- Patients with chronic renal failure (kidney dysfunction) associated with inherited polycystic kidney disease
- patients currently receiving treatment with epoetin for anemia secondary to chronic renal failure, and having a hemoglobin level \>11 g/dL
- patients receiving epoetin but having a hemoglobin level below 11 g/dL will not be excluded
- patients with severe hypertension (blood pressure \>= 180/110 mm Hg) within 3 months prior to study entry
- patients with a history of New York Heart Association (NYHA) class III or IV congestive heart failure within the preceding two years - NYHA class I and II congestive heart failure is accepted
- patients with a history of ischemic heart disease (deficient blood supply to the heart due to constricted or obstructed arteries)
- concurrent malignancy
- patients who have had a transfusion of red blood cells within 30 days prior to study
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2003
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT00312871
Start Date
February 1 2001
End Date
June 1 2003
Last Update
May 17 2011
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