A Study of the Safety and Efficacy of Long-term Correction of Anemia With Epoetin Alfa in Early Hemodialysis Patients

Phase 3

Completed

• Conditions: Kidney Failure, Chronic; Anemia

• Registration Number: NCT00261521
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary

The purpose of this study in early hemodialysis patients (on dialysis 3 to 18 months) is to assess the effect of correction versus partial correction of anemia using epoetin alfa on heart pumping function.

Detailed Description

Cardiovascular disease is very common among patients with end-stage renal disease. This study is a long-term, double-blind, parallel-group, multicenter study to determine the efficacy and safety of administering epoetin alfa to treat anemia (patients in Group 1) or partially treat anemia (patients in Group 2) in order to reduce the risk of heart failure in chronic renal failure patients on early dialysis and to improve their quality of life. Efficacy of epoetin alfa will be determined by comparing between Group 1 and Group 2 the heart structure (changes in left ventricle volume and mass viewed on echocardiograms), development of heart failure, correlation between changes in heart structure and hemoglobin level, a 6-minute walking test, and by 2 quality of life measures-a quality of life questionnaire and a fatigue questionnaire. Safety data associated with elevation of hemoglobin will be collected and monitored throughout the study: hemoglobin-related adverse events include thrombovascular events, seizures, and hypertension. Development of antibodies to erythropoetin over long-term treatment also will be assessed by serum samples gathered over the course of the study. The hypothesis of this study is that earlier and longer-term anemia intervention in patients without symptomatic heart disease or heart architecture distortions may conserve heart function and improve their quality of life, and that the intervention will be well tolerated by the patients. Patients not on epoetin alfa at start: epoetin alfa (50 IU/kg), 3 times per week with increases every 4 weeks at either 25 IU/kg or up to 25% of previous dose to reach target hemoglobin (Hb), then dose maintained. Patients on or switched to epoetin alfa at start are titrated to maintain target Hb.

Study Timeline

• Study Start: 2000-02
• Study Completion: 2003-05
• Study First Submitted: 2005-12-02
• Study First Submitted QC: 2005-12-02
• Study First Posted: 2005-12-05
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-02
• Last Update Posted: 2010-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 596

Inclusion Criteria

• On hemodialysis for 3 to 18 months and expected to remain on hemodialysis for at least two more years and with a life expectancy of a year or more
• Kidney transplant patients, whose transplant has failed, and now have been on hemodialysis for 3-18 months, may be eligible for the study, if they are not receiving excessive immunosuppression (e.g., <=10 mg of steroids/day allowed)
• Pre-dialysis hemoglobin 8-12 g/dL, inclusive, within the previous month (single reading is sufficient)
• Stable hemodialysis vascular access, within the previous 3 months
• No heart disease or asymptomatic heart disease without enlarged heart

Exclusion Criteria

• Heart diseases for which surgical intervention occurred during the previous two years or which may require intervention within the next year
• Patients with medical conditions likely to affect the response to epoetin
• Predialysis sitting diastolic blood pressure >= 100 mmHg on average for the previous month
• Folate, Vitamin B12, or transferrin deficiency
• History of seizure within 1 year
• Transfusion within 30 days prior to study entry.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent change in left ventricular volume index (LVVI) at Week 96.

Secondary Outcome Measures

Name	Time	Method
Percent change at Week 96 in left ventricular mass index (LVMI), development of new heart failure, correlation between change in left ventricular indices and average maintenance hemoglobin, 6-minute walking test, and quality of life.