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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 |
|---|---|---|
|
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. |
| Estimated Enrollment: | 150 |
| Study Start Date: | October 1997 |
| Estimated 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, 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| 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 |
|
Anemia epoetin alfa |
|
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 |