Myfortic in High MELD Liver Transplantation
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
Outcome
Outcome not reported
Stopped (Business): “funding was withdrawn”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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.