drugset / Trial / NCT01807767

Myfortic in High MELD Liver Transplantation

NCT01807767

RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of the study is to determine the efficacy and safety of Everolimus conversion in liver transplantation. Most large US liver centers transplant patients with high Model for End-Stage Liver Disease (MELD) scores. However, many of the sponsored liver transplant trials in the US do not include patients with high MELD scores making it difficult to extrapolate these trial data to the patients cared for at larger liver transplant centers. The greatest potential benefit of mammalian target of rapamycin (mTOR) inhibitors is the avoidance of the side-effects of calcineurin-inhibitors, namely, renal insufficiency, diabetes and hypertension. Therefore, this protocol is designed to study the efficacy and safety of everolimus and Myfortic in liver transplant patients with high MELD scores at two large centers with a vast experience in the administration of mTOR inhibitors.

Timeline

Start
2013-03
Primary completion
2015-07
Completion
2015-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule 1 mg
Subject Tacrolimus Small molecule
Background Mycophenolate Sodium Unknown 360 mg
Background Mycophenolate Sodium Unknown 720 mg

Indications

No indication recorded.