drugset / Trial / NCT03256864

Twice-daily Tacrolimus and Everolimus Convert to Once-daily Tacrolimus and Everolimus in Liver Transplant Recipient

NCT03256864

Phase 4 Completed 10 enrolled Chang Gung Memorial Hospital
RandomizedParallel-groupOpen-labelOther

Summary

It has been identified that nonadherence to immunosuppressant regimen may cause long-term graft failure and death in solid organ transplant recipients. Therefore, simplification of the immunosuppression regimen by reducing daily dosing frequency may improve long-term outcome. The investigators will examine pharmacokinetics and safety profiles of stable liver transplant recipients receiving twice-daily TAC with EVR (BID) regimen and then being converted to once-daily TAC with EVR (QD) regimen over a 6-month study period post-conversion.

Timeline

Start
2016-01
Primary completion
2019-06-30
Completion
2020-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule 1 mg
Subject Everolimus Small molecule 2 mg
Subject Tacrolimus Small molecule 0.1 mg/kg
Subject Tacrolimus Small molecule 0.2 mg/kg

Indications

No indication recorded.