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

Phase 4

Completed

Conditions: liver transplantation
10019654

Registration Number: NL-OMON55491

Lead Sponsor: Stichting Leveronderzoek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 106

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is a composite endpoint of any of three events: sustained<br /><br>(>3 months post randomization) new onset diabetes mellitus, eGFR < 60<br /><br>ml/minute/1.73 m2 for >3 months or new onset hypertension. Therefore, patients<br /><br>will reach the primary endpoint if any of the three events occurs. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The individual components of the composite end-point will also be analysed as<br /><br>separate secondary study outcomes.<br /><br>- Graft survival<br /><br>- Recipient survival<br /><br>- Number of episodes and severity of acute cellular rejection<br /><br>- Differences in prevalence and severity of tremor<br /><br>- Intra-patient variability<br /><br>- Metabolizing status of tacrolimus<br /><br>- Liver steatosis and fibrosis<br /><br>- Quality of life<br /><br>- patients will have AUC measurements of tacrolimus concentrations. </p><br>