Study Comparing in Livertransplantation Recipients With Tacrolimus Alone Versus Tacrolimus&Sirolimus

Liver Disease Clinical Trial

Official title: A Multicenter Randomized in Primary Livertransplantation Comparing Longterm Renal Function in Recipients Treated With Tacrolimus Alone and Recipients Treated With a Combination Tacrolimus and Sirolimus

Status Completed

Clinical Trial Summary

In this study we compare long term renal function in liver transplantation recipients treated with standard dose extended-release tacrolimus alone and recipients treated with a combination of low dose extended-release tacrolimus and low dose sirolimus. The hypothesis is that the patients treated with the combination have better long term renal function than the patients treated with standard dose tacrolimus alone.

Clinical Trial Description

To evaluate the effectiveness and safety of concentration controlled combination of once daily dosed low-dose sirolimus (trough levels: 3-5 ng/ml) and extended-release tacrolimus (trough levels:3-5 ng/ml), in order to provide superior renal function while maintaining comparable rates of patient and graft survival, compared to concentration controlled once - daily extended release tacrolimus (trough levels: 5-10 ng/ml) at 12, 24 and 36 months post-transplant. Moreover, to compare the incidence of de novo malignancy, the quality of life, fatigue and side effects between both treatment arms.

2.1 Primary objectives: To evaluate the effectiveness and safety of concentration controlled combination of low-dose sirolimus (trough levels: 3-5 ng/ml) and extended-release tacrolimus (trough levels: 3-5 ng/ml), in order to provide superior renal function while maintaining comparable rates of patient and graft survival, compared to concentration controlled once - daily extended release tacrolimus (trough levels:-10 ng/ml) control at 12, 24 and 36 months post-transplant.

2.2. Secondary objectives:

• To compare the incidence of de novo and recurrence of cancer between study arm and control arm at 36 months.

• To compare the incidence and severity of biopsy proven acute rejection between study arm and control arm at 12, 24 and 36 months.

• To evaluate renal function at 12, 24 and 36 months (calculated GFR).

• To evaluate the development of new onset diabetes mellitus at 12, 24 and 36 months post transplant

• To evaluate the prevalence of CNI side effects at 12, 24 and 36 months

• To evaluate quality of life (Eq5D) and fatigue severity score at 12, 24 and 36 months

• To evaluate the percentage of patients on combination tacrolimus and sirolimus and converted back to tacrolimus mono-therapy. ;

Related Conditions & MeSH terms

• Liver Disease
• Liver Diseases

• NCT number: NCT01958190
• Study type: Interventional
• Source: Foundation for Liver Research
• Status: Completed
• Phase: Phase 4
• Start date: February 7, 2011
• Completion date: May 20, 2021