drugset
drugset / Trial / NCT03968588

Standard- Versus Reduced-dose Tacrolimus Combined With Generic Mycophenolate Mofetil in De Novo Renal Transplantation

NCT03968588 ↗

Phase 4 Completed 108 enrolled Ajou University School of Medicine
RandomizedParallel-groupOpen-labelTreatment

Summary

A prospective, multicenter, open-label, randomized and parallel-group clinical trial was conducted at four transplant centers in Korea. This clinical study was designed to compare the efficacy and tolerability of reduced-dose tacrolimus with standard-dose mycophenolate mofetil (MMF) versus standard-dose tacrolimus with reduced-dose MMF.

Timeline

Start
2014-07-29
Primary completion
2016-11-11
Completion
2017-06-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Mycophenolate Mofetil Small molecule 0.5 g —
Subject Mycophenolate Mofetil Small molecule 1 g —
Subject Mycophenolate Mofetil Small molecule 1.5 g —
Subject Mycophenolate Mofetil Small molecule 2 g —
Subject Tacrolimus Small molecule — —

Indications

disease related to solid organ transplantation