drugset / Trial / NCT02683291

Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients

NCT02683291

Phase 4 Completed 48 enrolled Associação Médico Espírita de Botucatu
RandomizedParallel-groupSingle-blindTreatment

Summary

There is no consensus on the best immunosuppressive regimen in elderly people. The aim of this study will be to evaluate the efficacy of sirolimus associated with tacrolimus in elderly kidney transplant recipients. The investigators will conduct a single-center prospective randomized study comparing the combination of tacrolimus with sirolimus at reduced dose rate (tacrolimus + sirolimus group) against tacrolimus with mycophenolate (tacrolimus + mycophenolate group). The investigators will include all kidney transplant patients over 60 years of age. The investigators will evaluate estimated glomerular filtration rate and incidence of cytomegalovirus in 12 month follow-up.

Timeline

Start
2014-01
Primary completion
2015-01
Completion
2016-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Mycophenolate Sodium Unknown 720 mg
Subject Sirolimus Small molecule 2 mg
Background Basiliximab Monoclonal antibody 20 mg
Background Prednisone Other / unclassified 5 mg
Background Tacrolimus Small molecule 0.1 mg/kg
Background Thymoglobulin Protein / enzyme biologic 1 mg/kg