Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121784
Status:
TERMINATED
Last Update Posted:
2016-11-02
First Post:
2005-07-15
Brief Title:
Heart Spare the Nephron STN Study - A Study of CellCept Mycophenolate Mofetil and Rapamune Sirolimus in Heart Transplant Recipients
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Open-label Study of the Effect of Replacing CNI With Sirolimus in a Standard Care Regimen of CNI CellCept and Steroids on Renal Function in Heart Transplant Patients
Status:
TERMINATED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Heart transplant patients on a standard care regimen of CNI MMF and corticosteroids will enter the study 4-6 weeks post-transplant At 3 months after transplant patients will be randomized to either continue this regimen or CNI therapy will be discontinued and replaced by sirolimus therapy in combination with MMF and corticosteroids The effect of these 2 regimens on efficacy safety and renal function will be evaluatedThe anticipated time on study treatment is 1-2 years and the target sample size is 500 individuals
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None