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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-12-31

Study Completion Date

2003-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anemia Kidney Failure Left Ventricular Hypertrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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epoetin alfa

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No