A Safety and Efficacy Study for Epoetin Alfa in Pre-dialysis Subjects.

Phase 3

Completed

• Conditions: Anemia; Kidney Failure; Left Ventricular Hypertrophy

• Registration Number: NCT00364260
• Lead Sponsor: Janssen-Ortho Inc., Canada

Brief Summary

The purpose of this study is to determine if using Eprex, to maintain hemoglobin within the normal range, will prevent or delay the progression of left ventricular mass growth.

Detailed Description

Cardiovascular disease continues to be the major cause of morbidity and mortality in subjects with renal (kidney) disease. Left ventricular hypertrophy (LVH) has been correlated with a high risk of cardiac and all cause mortality. In the renal population , many factors have been shown to be important in the development of LVH, including anemia. This is a multicentre, open, controlled, randomized trial to determine if maintaining hemoglobin within the normal range delays the progress of left ventricular mass growth. Additionally, this study will evaluated the safety of maintaining hemoglobin within the normal range in pre-dialysis subjects. The trial duration is 24 months. Subjects randomized to the treatment arm will receive Eprex therapy to maintain hemoglobin between 120-140 g/L. Subjects randomized to the control arm will not receive any treatment unless their hemoglobin falls to less than or equal to 90 g/L. Those subjects will then be treated to maintain their hemoglobin between 90-105 g/L. The subjects were to receive injections of Eprex once weekly to maintain hemoglobin levels within the target range for the arm to which they were randomized. The subjects were to receive treatment for up to 24 months.

Study Timeline

• Study Start: 1997-12
• Study Completion: 2003-08
• Study First Submitted: 2006-08-11
• Study First Submitted QC: 2006-08-14
• Study First Posted: 2006-08-15
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-31
• Last Update Posted: 2011-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

• Patients have had a decrease in hemoglobin >= 10 g/L within the past 12 months and a current hemoglobin level between 110-135 g/L (men) and 100-135 g/L (women) OR a hemoglobin level between 115-125 g/L (men) and 110-120 g/L (women)
• Have a calculated creatinine clearance <80 mL/min and >15 mL/min

Exclusion Criteria

• No uncontrolled hypertension (diastolic blood pressure>= 105 mm Hg on average for the previous month)

No unstable angina or cardiac procedure within the past 12 months or a planned procedure

• No myocardial infarction with the past 12 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The change in left ventricular mass index from baseline to 24 months as measured by 2-dimensional targeted M-mode echocardiography.

Secondary Outcome Measures

Name	Time	Method
The difference in renal function (calculated creatinine clearance) between groups at 24 months; The functional cardiac status (NYHA/CCS classification) between groups at 24 months;The change in SF-36 scores between groups from baseline to 24 months