MOdifying Tacrolimus related TOxicity after liver transplantation

MOdifying Tacrolimus related TOxicity after liver transplantation (MOTTO). A randomized controlled trial comparing Envarsus® versus Advagraf® in de novo liver transplant recipients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24720

Enrollment

106

Registered

2018-09-20

Start date

2019-04-11

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

Liver transplantation LTx, HCC,

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - First liver transplantation - Age between 18 and 75 - Using immediate release tacrolimus - written informed consent - Female subject of childbearing potential must agree to practice effective birth control

Exclusion criteria

Exclusion criteria: - Pregnancy or breast feeding - 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
A composite endpoint of any of three events: sustained (>3 months post transplantation) new onset diabetes mellitus, eGFR < 60 ml/minute/1.73 m2 for >3 months or new onset hypertension.	—

Secondary

Measure	Time frame
- Drug compliance - Quality of life - Neurotoxicity in terms of tremors, cognitive impairment, sleep quality - Pharmacokinetics and –dynamics - Drug metabolism - Liver steatosis and fibrosis - Efficacy in terms of graft and patient survival and episodes of acute cellular rejection, chronic rejection, antibody mediated rejection	—

Outcome results