Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123331
Status:
COMPLETED
Last Update Posted:
2005-08-02
First Post:
2005-07-18
Brief Title:
Rapamycin Use in Calcineurin Inhibitor CNI-Free Immunosuppression for StabilizationImprovement of Renal Function After Heart Transplantation
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
Rapamycin Use in CNI-Free Immunosuppression for StabilizationImprovement of Renal Function After Heart Transplantation
Status:
COMPLETED
Status Verified Date:
2005-06
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:
Clinical Problem Renal insufficiency after heart transplantation caused by cyclosporine medication was addressed Current therapeutic approaches include cyclosporine reduction or discontinuation It is unclear whether discontinuation of low dose cyclosporine also has a beneficial effect ie is there a threshold effect for cyclosporine nephrotoxicity
Study Design Heart transplant patients with a moderate degree of renal failure on low dose cyclosporine were randomized to either a no change or b discontinuation of cyclosporine and initiation of rapamycin immunosuppression
Read-Out Renal function after 6 months tolerability and safety were assessed
Study Design Heart transplant patients with a moderate degree of renal failure on low dose cyclosporine were randomized to either a no change or b discontinuation of cyclosporine and initiation of rapamycin immunosuppression
Read-Out Renal function after 6 months tolerability and safety were assessed
Detailed Description:
Clinical Problem Renal insufficiency after heart transplantation caused by cyclosporine medication was addressed Current therapeutic approaches include cyclosporine reduction or discontinuation It is unclear whether discontinuation of low dose cyclosporine also has a beneficial effect ie is there a threshold effect for cyclosporine nephrotoxicity
Study Design Heart transplant patients with a moderate degree of renal failure on low dose cyclosporine were randomized to either a no change or b discontinuation of cyclosporine and initiation of rapamycin immunosuppression
Read-Out Renal function after 6 months tolerability and safety were assessed
Study Design Heart transplant patients with a moderate degree of renal failure on low dose cyclosporine were randomized to either a no change or b discontinuation of cyclosporine and initiation of rapamycin immunosuppression
Read-Out Renal function after 6 months tolerability and safety were assessed
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