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

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 3

Conditions

Kidney Failure

Anemia

Left Ventricular Hypertrophy

Treatments

Drug: epoetin alfa

Study type

Interventional

Funder types

Industry

Identifiers

NCT00364260

CR002056

Details and patient eligibility

About

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.

Full 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.

Enrollment

172 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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