NCT01807767

Myfortic in High MELD Liver Transplantation

Prospective Evaluation of the Efficacy and Safety of Zortress (Everolimus)/Myfortic (Enteric Coated Mycophenolate Sodium) Conversion in High MELD Liver Transplantation

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• High Model for End-Stage Liver Disease (MELD) Score

Interventions

Type	Name	Description
DRUG	Everolimus, Myfortic and Tacrolimus	Tacrolimus discontinued (within 8 weeks of initiation of everolimus conversion). Everolimus 1mg BID started (targeted trough 6-12ng/mL). Patients must have an everolimus concentration between 6-12ng/mL before tacrolimus is discontinued. Myfortic 360-720 mg BID
DRUG	Myfortic and Tacrolimus	Myfortic BID 360-720 mg Tacrolimus (5-12ng/mL)

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-07-01
• Completion: 2015-08-01
• First posted: 2013-03-08
• Last updated: 2019-10-21

Locations

1 site across 1 country: United States