Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00166712
Status:
TERMINATED
Last Update Posted:
2015-10-26
First Post:
2005-09-09
Brief Title:
A Trial of Two Steroid-Free Approaches Toward Mycophenolate Mofetil-Based Monotherapy Immunosuppression
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Phase IV Single Center Pilot Study Using Alemtuzumab Campath-1H Induction Combined With Prednisone-Free Calcineurin-Inhibitor-Free Immunosuppression in Kidney Transplantation
Status:
TERMINATED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study stopped due to lack of efficacy funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Cell220
Brief Summary:
This is an open label single-center randomized phase IV pilot study of steroid and calcineurin inhibitor avoidance in renal transplant recipients All patients will receive two doses of alemtuzumab to achieve peripheral T-cell depletion Intravenous glucocorticoids will be administered prior to alemtuzumab administration to limit cytokine release syndrome in association with this monoclonal antibody and continued for the first two days post-transplant Thereafter steroids will not be used for immunosuppression All transplant recipients will be started on oral immunosuppressive therapy with mycophenolate mofetil MMF prior to transplant Pretransplant these patients will be randomized to receive in addition either tacrolimus Tac or sirolimus
After six months patients in the tacrolimus arm who do not experience rejection will be randomized to continue on tacrolimus or to be converted to the combination of sirolimus and MMF Individuals in this arm of the study who do not experience acute rejection and demonstrate evidence of donor specific hyporesponsiveness at 9 months post-transplant those staying on Tac MMF or 3 months post-conversion those converted from Tac MMF to sirolimus MMF will be weaned to MMF monotherapy
Individuals in the sirolimus MMF arm who do not experience acute rejection and demonstrate evidence of donor specific hyporesponsiveness at 6 months post-transplant will be weaned to MMF monotherapy
After six months patients in the tacrolimus arm who do not experience rejection will be randomized to continue on tacrolimus or to be converted to the combination of sirolimus and MMF Individuals in this arm of the study who do not experience acute rejection and demonstrate evidence of donor specific hyporesponsiveness at 9 months post-transplant those staying on Tac MMF or 3 months post-conversion those converted from Tac MMF to sirolimus MMF will be weaned to MMF monotherapy
Individuals in the sirolimus MMF arm who do not experience acute rejection and demonstrate evidence of donor specific hyporesponsiveness at 6 months post-transplant will be weaned to MMF monotherapy
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CNV0042139 | OTHER_GRANT | Roche Laboratories Inc | None |