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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54925

Enrollment

Registered

2021-04-15

Start date

2021-06-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Mycoses due to opportunistic pathogens

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Lung, kidney, pancreas or heart transplant recipient - Age >18 years - Stable use of tacrolimus formulations Prograf/generic tacrolimus/Envarsus - Indication for antifungal therapy with voriconazole - Written informed consent

Exclusion criteria

Exclusion criteria: - Administration of mTOR inhibitors, cyclosporine or quadruple immunosuppression - Concomitant use of drugs that have a pharmacokinetic interaction with tacrolimus - Acute liver- or intestinal function impairment - Pregnancy

Design outcomes

Primary

Measure	Time frame
To assess whether IR-Tac and ER-Tac exhibit a different magnitude of drug-drug interaction after co-administration of voriconazole in lung, kidney, pancreas or heart transplant recipients.	—

Secondary

Measure	Time frame
- To describe all relevant PK parameters for IR-Tac and ER-Tac, their fold-change after azole initiation and the relevant azole PK parameters (which are: Cmax, dose-adjusted Cmax, Cmin, dose-adjusted Cmin, Tmax, t1/2). - To describe whether pharmacogenetic genotype and inflammatory markers have an additional influence on tacrolimus and azole pharmacokinetics - To investigate whether and with what extend the interaction diminishes over time after discontinuation of the interacting drug, as measured with Cmin/dose ratio - To evaluate how tacrolimus dose should be adjusted at start and discontinuation of the voriconazole, and how many dose adjustments are needed for both formulations	—

Measure

Time frame

- To describe all relevant PK parameters for IR-Tac and ER-Tac, their fold-change after azole initiation and the relevant azole PK parameters (which are: Cmax, dose-adjusted Cmax, Cmin, dose-adjusted Cmin, Tmax, t1/2). - To describe whether pharmacogenetic genotype and inflammatory markers have an additional influence on tacrolimus and azole pharmacokinetics - To investigate whether and with what extend the interaction diminishes over time after discontinuation of the interacting drug, as measured with Cmin/dose ratio - To evaluate how tacrolimus dose should be adjusted at start and discontinuation of the voriconazole, and how many dose adjustments are needed for both formulations

—

Countries

Netherlands

Outcome results