Ignite Creation Date:
2024-05-05 @ 10:40 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01166724
Status:
TERMINATED
Last Update Posted:
2017-06-07
First Post:
2010-07-20
Brief Title:
Renal Allograft Function and Histology Following Switching From A Tacrolimus to Sirolimus SRL-Based Immunosuppression-
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Renal Allograft Function and Histology Following Switching From A Tacrolimus to Sirolimus SRL-Based Immunosuppression- Clinical and Mechanistic Impact
Status:
TERMINATED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Collaborator stopped study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators hypothesize that Tacrolimus Tac withdrawal from a Tac MMF and steroid based triple therapy regimen leads to long term improvedstabilized graft function glomerular filtration rate GFR primarily as a consequence of halting CNI-induced fibrogenetic processes that mediate loss of functioning renal tissue The investigators further hypothesize that the underlying fibrotic mechanism is mediated by pathophysiologic processes that promote epithelial to mesenchymal transition EMT mediated by TGF- ƒÒ and that early therapeutic intervention may reverse this process mediated by BMP-74
To address these hypotheses the investigators propose the following clinical and mechanistic aims
The investigators will test the hypothesis that switching from Tac to SRL in a Tac based triple therapy regimen with MMF and steroids in living and or deceased donor renal transplant recipients leads to improvement in allograft structure and function at 2 years post-transplantation
The investigators will test this hypothesis in an open label controlled trial where stable renal allograft recipients on Tac MMF prednisone maintenance immunosuppression will undergo renal biopsy at 3-4 months post-transplantation and will be randomized to either a Remain on Tac MMF and prednisone CNI-maintenance or b switch the Tac to SRL and continue MMF and prednisone The investigators will then compare biopsy derived measures of allograft fibrosis CADI Sirius Red Banff Chronicity Index and GFR in the two groups
To address these hypotheses the investigators propose the following clinical and mechanistic aims
The investigators will test the hypothesis that switching from Tac to SRL in a Tac based triple therapy regimen with MMF and steroids in living and or deceased donor renal transplant recipients leads to improvement in allograft structure and function at 2 years post-transplantation
The investigators will test this hypothesis in an open label controlled trial where stable renal allograft recipients on Tac MMF prednisone maintenance immunosuppression will undergo renal biopsy at 3-4 months post-transplantation and will be randomized to either a Remain on Tac MMF and prednisone CNI-maintenance or b switch the Tac to SRL and continue MMF and prednisone The investigators will then compare biopsy derived measures of allograft fibrosis CADI Sirius Red Banff Chronicity Index and GFR in the two groups
Detailed Description:
We will test this hypothesis in an open label controlled trial where stable renal allograft recipients on Tac MMF prednisone maintenance immunosuppression will undergo renal biopsy at 3-4 months post-transplantation and will be randomized to either a Remain on Tac MMF and prednisone CNI-maintenance or b switch the Tac to SRL and continue MMF and prednisone We will then compare biopsy derived measures of allograft fibrosis CADI Sirius Red Banff Chronicity Index and GFR in the two groups
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