Management of the combination of tacrolimus with azoles: effect of tacrolimus formulation on drug-drug interaction magnitude
Recruiting
- Conditions
- Fungal infections
- Registration Number
- NL-OMON28458
- Lead Sponsor
- MCG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 48
Inclusion Criteria
Age >18 years
-Lung, kidney, pancreas or heart transplant recipient
- Stable use of oral tacrolimus formulations Prograft/generic tacrolimus/Envarsus
-eGFR >20 ml/min
-Indication for antifungal therapy with oral voriconazole or fluconazole
-Written informed consent
Exclusion Criteria
-Administration of mTOR inhibitors, cyclosporine or quadruple immunosuppression
-Pregnancy
-Concomitant use of drugs that have a pharmacokinetic interaction with tacrolimus
-Acute liver- or intestinal function impairment (liver function over 3 times the reference values; function impairment started in week before 1st study visit and/or expected to be instable for the next weeks)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dose-adjusted increase in AUC of IR-Tac and ER-Tac
- Secondary Outcome Measures
Name Time Method PK parameters, correlation of PK parameters with pharmacogenetic genotype inflammatory markers, Cmin/dose ratio during and after azole treatment, number of dose adjustments and total dose adjustment needed