Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-02-09 @ 6:37 AM
Study NCT ID:
NCT00364260
Status:
COMPLETED
Last Update Posted:
2011-02-01
First Post:
2006-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety and Efficacy Study for Epoetin Alfa in Pre-dialysis Subjects.
Sponsor:
Janssen-Ortho Inc., Canada
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: