MOdifying Tacrolimus related TOxicity after liver transplantatio
- Conditions
- <p>Liver transplantation</p>LTx, HCC,
- Registration Number
- NL-OMON24720
- Lead Sponsor
- Stichting Lever en Maag Darm onderzoek, Erasmus MC
- Brief Summary
Significantly less liver transplant recipients reached the composite primary endpoint at 12 months in the LCP-tacrolimus group compared to the extended-release tacrolimus group (50.9%, 95%-CI 37.9% - 63.9% versus 71.2%, 95%-CI 57.7% - 81.7%, p=0.005). This significant difference was observed both in the intention-to-treat and in the per protocol analysis. No differences in rejection rate, graft and patient survival were found. In conclusion, LCP-tacrolimus has a more favorable cardiovascular risk profile and results in less chronic kidney disease as compared to ER-tacrolimus in the first year after liver transplantation with comparable efficacy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 106
- First liver transplantation
- Age between 18 and 75
- Pregnancy or breast feeding
- eGFR < 30 mL/min/1.73m2
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>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.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Drug compliance<br /><br>- Quality of life<br /><br>- Neurotoxicity in terms of tremors, cognitive impairment, sleep quality<br /><br>- Pharmacokinetics and –dynamics<br /><br>- Drug metabolism<br /><br>- Liver steatosis and fibrosis<br /><br>- Efficacy in terms of graft and patient survival and episodes of acute cellular rejection, chronic rejection, antibody mediated rejection</p><br>