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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00364260
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : February 1, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Anemia Kidney Failure Left Ventricular Hypertrophy Drug: epoetin alfa Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Study to Determine the Impact of Hemoglobin Maintenance and Other Interventional Strategies to Prevent or Delay the Progression of Left Ventricular Mass Growth in Subjects With Early Renal Insufficiency.
Study Start Date : December 1997
Actual Study Completion Date : August 2003

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. The change in left ventricular mass index from baseline to 24 months as measured by 2-dimensional targeted M-mode echocardiography.

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00364260

Sponsors and Collaborators
Janssen-Ortho Inc., Canada
Study Director: Janssen-Ortho Inc. Clinical Trial Janssen-Ortho Inc., Canada

Publications of Results: Identifier: NCT00364260     History of Changes
Other Study ID Numbers: CR002056
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: February 1, 2011
Last Verified: January 2011

Keywords provided by Janssen-Ortho Inc., Canada:
epoetin alfa

Additional relevant MeSH terms:
Renal Insufficiency
Hypertrophy, Left Ventricular
Kidney Diseases
Urologic Diseases
Pathological Conditions, Anatomical
Heart Diseases
Cardiovascular Diseases
Epoetin Alfa