Overview

Planned Conversion From TAC to SRL-based Regimen in de Novo Kidney Transplant Recipients

Status:
Completed
Trial end date:
2012-10-01
Target enrollment:
Participant gender:
Summary
Background Early conversion from calcineurin inhibitor to mammalian target of rapamycin inhibitor is one of the immunosuppressive strategies that have been investigated to mitigate long-term CNi associated adverse events. This study aims to evaluate the conversion from tacrolimus to sirolimus in de novo kidney transplant recipients. This multicenter, open-label study, planned to enroll 297 patients initially treated with tacrolimus, enteric-coated mycophenolate sodium (1440 mg/day, orally) and prednisone. The primary objective is to show superior glomerular filtration rate in the SRL group at 24 months after transplantation.
Phase:
Phase 4
Details
Lead Sponsor:
Helio Tedesco Silva Junior
Collaborator:
Pfizer
Treatments:
Everolimus
Sirolimus
Tacrolimus