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A Safety and Efficacy Study for Epoetin Alfa in Pre-Dialysis Subjects.
This study has been completed.
First Received: August 11, 2006   Last Updated: May 18, 2007   History of Changes
Sponsor: Janssen-Ortho Inc., Canada
Information provided by: Janssen-Ortho Inc., Canada
ClinicalTrials.gov Identifier: NCT00364260
  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
Left Ventricular Hypertrophy
Anemia
Kidney Failure
Drug: epoetin alfa
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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 mesaured 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

Estimated Enrollment: 150
Study Start Date: October 1997
Estimated 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, contolled, randomized trial to determine if maintaining hemoglobin within the normal range delays the progess of left venticular 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
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:
Study ID Numbers: CR002056
Study First Received: August 11, 2006
Last Updated: May 18, 2007
ClinicalTrials.gov Identifier: NCT00364260     History of Changes
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on February 08, 2010