Management of the combination of tacrolimus with azoles: effect of tacrolimus formulation on drug-drug interaction magnitude

‘Tacrolimus and Azoles: effect of tacrolimus Formulation on drug-drug Interaction study’

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON28458

Enrollment

Registered

2020-11-26

Start date

2021-06-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fungal infections

Interventions

blood draws

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Dose-adjusted increase in AUC of IR-Tac and ER-Tac	—

Secondary

Measure	Time frame
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	—

Contacts

Public ContactTanja Zijp

Universitair Medisch Centrum Groningen

t.r.zijp@umcg.nl050-3617876

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)