Effects of Early Correction of Anemia in Patients With Chronic Renal Insufficiency

• Status: Terminated
• Trial end date: 2003-06-01
• Target enrollment: 0
• Participant gender: All

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 improper functioning of the kidneys). It also assesses the effect of hemoglobin normalization (correction of anemia) on the need for renal (kidney) replacement therapy, quality of life, blood pressure control, hospital admissions, mortality, cardiovascular events, nutritional status and safety.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Cilag S.A.S.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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