Ignite Creation Date:
2024-05-06 @ 1:56 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01935128
Status:
COMPLETED
Last Update Posted:
2022-05-26
First Post:
2013-08-21
Brief Title:
Evaluation of Calcineurin-inhibitor Reduction With Conversion at 2 Months to EverolimusReduced Tacrolimus in Renal Transplant Recipients Following Campath Induction
Sponsor:
University of Toledo Health Science Campus
Organization:
University of Toledo
Study Overview
Official Title:
A 24-month Single Center Pilot Open Label Controlled Trial to Evaluate the Efficacy and Safety of Calcineurin-inhibitor Reduction With Conversion at 2 Months to Reduced Dose TacrolimusEverolimus in Adult Renal Transplant Recipients Following Campath Induction and Steroid Avoidance
Status:
COMPLETED
Status Verified Date:
2022-05
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 evaluate whether conversion to everolimus Zortress allowing the elimination or reduction of calcineurin inhibitors will reduce nephrotoxicity measured by increased creatinine clearance and lengthen overall graft kidney transplant survival measured by 2-3 year graft survival
Detailed Description:
The purpose of this study is to evaluate whether conversion to everolimus Zortress allowing the elimination or reduction of calcineurin inhibitors will reduce nephrotoxicity measured by increased creatinine clearance and lengthen overall graft kidney transplant survival measured by 2-3 year graft survival Among the worst of the long-term effects of chronic immunosuppression are the nephrotoxicity toxic to kidney cells of the calcineurin inhibitors and the myriad complications of steroids This protocol evaluates the elimination or reduction of calcineurin inhibitors in a protocol that has already successfully eliminated the long-term use of steroids A considerable need remains for safer therapeutic agents that inhibit T-cell activation a white blood cell that attacks foreign cells as part of the immune response via a calcineurin independent or reduced-dose mechanism of action
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