NCT01888432

Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants

A 24 Month, Randomized, Controlled, Study to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus Plus Reduced Tacrolimus Compared to Standard Tacrolimus in Recipients of Living Donor Liver Transplants and Long Term Extension to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus Plus Reduced Tacrolimus Compared to Standard Tacrolimus in Recipients of Living Donor Liver Transplants in Japan

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 285 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial was to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients.

Detailed description

This study was 24 month, multicenter study in 280 living donor liver transplant patients from Asia, Europe and Canada. The study has an long term extension in Japan and approximately 28 patients were to be included to evaluate the long-term efficacy and safety of concentration-controlled everolimus regimen plus reduced tacrolimus compared to standard tacrolimus in recipients of living donor liver transplants in Japan who participated in the CRAD001H2307 study. Data reported here are the CRAD001H2307 core study results and its extension (CRAD001H2307E1).

Conditions

• Liver Transplantation

Interventions

Type	Name	Description
DRUG	Everolimus + reduced tacrolimus	Everolimus was initiated at Week 4 post transplantation. The dose was adjusted to maintain the everolimus trough blood levels between 3-8 ng/mL for the duration of the study. Tacrolimus was reduced to 3-5 ng/mL.
DRUG	Standard tacrolimus	Tacrolimus was initiated as soon as possible after transplantation according to approved labeling recommendations. The trough level should've been 5-15 ng/mL until randomization, 8-12 ng/mL from randomization until month 4 and after month 4 until end of study reduced to 6 -10 ng/mL.

Timeline

• Start date: 2013-09-25
• Primary completion: 2016-10-19
• Completion: 2018-04-21
• First posted: 2013-06-27
• Last updated: 2019-03-18
• Results posted: 2018-11-13

Locations

42 sites across 13 countries: United States, Canada, Egypt, Germany, India, Italy, Japan, Russia, Saudi Arabia, Singapore, South Korea, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study