No registrations found.
ID
Source
Brief title
Health condition
Fungal infections
Sponsors and support
Intervention
Outcome measures
Primary outcome
Dose-adjusted increase in AUC of IR-Tac and ER-Tac
Secondary outcome
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
Background summary
Tacrolimus treatment is delicate and increases risk of (invasive) fungal infections, which need azole treatment. Tacrolimus and azoles exhibit drug-drug interactions through CYP3A4/5 enzymes in gut and liver, increasing tacrolimus exposure. The choice of tacrolimus formulation for immediate release tacrolimus (IR-Tac) or extended release tacrolimus (ER-Tac) may influence the magnitude of the interaction with azoles, as shown in healthy volunteers. This effect has not been studied in a patient population under real-life conditions yet, and may influence future choice of formulation, dosage adjustment advices and treatment management.
Study objective
Whether the formulation of tacrolimus affects the intensity and variability of the drug-drug interaction with co-administered azoles fluconazole or voriconazole in lung, kidney, pancreas or heart transplant recipients
Study design
Baseline, after >4d of azole use
Intervention
blood draws
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)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9080 |
| Other | METC UMCG : 2020/645 |