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

This study has been completed.
Sponsor:
Information provided by:
Janssen-Ortho Inc., Canada
ClinicalTrials.gov Identifier:
NCT00364260
First received: August 11, 2006
Last updated: January 31, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Anemia
Kidney Failure
Left Ventricular Hypertrophy
Drug: epoetin alfa
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Janssen-Ortho Inc., Canada:

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

Secondary Outcome Measures:
  • 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

Enrollment: 172
Study Start Date: December 1997
Study Completion Date: August 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364260

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

Publications:
ClinicalTrials.gov Identifier: NCT00364260     History of Changes
Other Study ID Numbers: CR002056
Study First Received: August 11, 2006
Last Updated: January 31, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Anemia
Hypertrophy
Renal Insufficiency
Hypertrophy, Left Ventricular
Hematologic Diseases
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Cardiomegaly
Heart Diseases
Cardiovascular Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014