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

Kidney Transplant Clinical Trial

Official title:
Outcomes of Planned Conversion From Tacrolimus to Sirolimus-based Immunosuppressive Regimen in de Novo Kidney Transplant Recipients

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01802268
Study type Interventional
Source Hospital do Rim e Hipertensão
Contact
Status Completed
Phase Phase 4
Start date February 2008
Completion date October 2012
View Details
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