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| 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 |
|---|---|---|
|
Anemia Kidney Failure Left Ventricular Hypertrophy |
Drug: epoetin alfa |
Phase III |
| 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. |
| Enrollment: | 172 |
| Study Start Date: | December 1997 |
| Study Completion Date: | August 2003 |
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 |
Inclusion Criteria:
Exclusion Criteria:
No unstable angina or cardiac procedure within the past 12 months or a planned procedure
Contacts and Locations
More Information
| 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 |
|
Anemia epoetin alfa |
|
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 |