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
ID
Bron
Verkorte titel
Aandoening
Fungal infections
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Dose-adjusted increase in AUC of IR-Tac and ER-Tac
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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
Onderzoeksopzet
Baseline, after >4d of azole use
Onderzoeksproduct en/of interventie
blood draws
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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)
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9080 |
| Ander register | METC UMCG : 2020/645 |