Envarsus® will be compared with the current standard treatment Advagraf® after liver transplantation.

Modifying tacrolimus related toxicity after liver transplantation. A randomized controlled trial comparing Envarsus® and Advagraf® in de novo liver transplant recipients. - MOTTO

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002856-34-NL

Enrollment

106

Registered

2018-10-30

Start date

2019-03-01

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver transplantation MedDRA version: 20.0 Level: PT Classification code 10024715 Term: Liver transplant rejection System Organ Class: 10021428 - Immune system disorders

Interventions

Trade Name: Envarsus Pharmaceutical Form: Prolonged-release tablet Trade Name: Advagraf Pharmaceutical Form: Prolonged-release capsule, hard

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • First liver transplantation • Age between 18 and 75 • Using immediate release tacrolimus • Female subjects of childbearing potential must agree to practice effective birth control during the study • Informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26

Exclusion criteria

Exclusion criteria: • Pregnancy • eGFR < 30 mL/min/1.73m2 • Systemic infection • Combined organ transplantation • Use of a mTOR inhibitor • Use of other tacrolimus formulations • Hepatic artery trombosis • Known allergy to the study drug or any of its components

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to investigate whether Envarsus® leads to a significant reduction in new onset diabetes, chronic kidney disease and new onset hypertension. ;Secondary Objective: not applicable;Primary end point(s): The primary endpoint is a composite endpoint of any of three events: sustained (>3 months post transplantation) new onset diabetes mellitus, eGFR 3 months or new onset hypertension.;Timepoint(s) of evaluation of this end point: 2nd quarter 2023	—

Measure

Time frame

Main Objective: The primary objective of this study is to investigate whether Envarsus® leads to a significant reduction in new onset diabetes, chronic kidney disease and new onset hypertension. ;Secondary Objective: not applicable;Primary end point(s): The primary endpoint is a composite endpoint of any of three events: sustained (>3 months post transplantation) new onset diabetes mellitus, eGFR 3 months or new onset hypertension.;Timepoint(s) of evaluation of this end point: 2nd quarter 2023

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Secondary

Measure	Time frame
Secondary end point(s): - The individual components of the composite end-point will also be analysed as separate secondary study outcomes - Graft survival - Recipient survival - Number of episodes and severity of acute cellular rejection, chronic rejection, antibody mediated rejection - Differences in incidence and severity of tremor - Intra-patient variability - Metabolizing status of tacrolimus - Liver steatosis and fibrosis - Quality of life;Timepoint(s) of evaluation of this end point: LVLS = 4th Q 2022	—

Measure

Time frame

Secondary end point(s): - The individual components of the composite end-point will also be analysed as separate secondary study outcomes - Graft survival - Recipient survival - Number of episodes and severity of acute cellular rejection, chronic rejection, antibody mediated rejection - Differences in incidence and severity of tremor - Intra-patient variability - Metabolizing status of tacrolimus - Liver steatosis and fibrosis - Quality of life;Timepoint(s) of evaluation of this end point: LVLS = 4th Q 2022

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Countries

Netherlands

Contacts

Public ContactCoordinating Investigator

Erasmus MC

c.denhoed@erasmusmc.nl0031642263231

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026