drugset / Trial / NCT03468478

Comparison of the Efficacy and Safety of Sirolimus Versus Everolimus Versus Mycophenolate in Kidney Transplantation

NCT03468478

Phase 4 Completed 1209 enrolled Hospital do Rim e Hipertensão
RandomizedParallel-groupOpen-labelPrevention

Summary

This study was designed to compare 3 immunosuppression regimens: sirolimus and tacrolimus versus everolimus and tacrolimus versus mycophenolate and tacrolimus. The primary outcome is the incidence of cytomegalovirus infection / disease, a relevant medical need in the absence of pharmacological prophylaxis.

Timeline

Start
2017-06-18
Primary completion
2021-03-18
Completion
2021-08-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule 1.5 mg
Subject Sirolimus Small molecule 3 mg
Comparator mycophenolic acid Small molecule 720 mg
Comparator mycophenolic acid Small molecule 1 g