cystic fibrosis patients
Conditions
Interventions
Trade Name: Kaftrio
Pharmaceutical Form: Film-coated tablet
Sponsors
Haga Teaching Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Males and females aged 18 years or older on the date of informed consent -Diagnosis of cystic fibrosis with a genotype registered for the use of elexacaftor/tezacaftor/ivacaftor confirmed by genotype analysis. -Kidney or liver transplantation > 1 year ago -Current use of tacrolimus -Signed informed consent form (ICF) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Use of drugs that are metabolized by the CYP3A enzyme or have a known influence on the CYP3A enzyme (inducers or inhibitors) -Having a contra indication for the use of elexacaftor/tezacaftor/ivacaftor -Organ rejection within the last 3 months -Pulmonary exacerbation within one month before the study period (defined as need for intravenous antibiotics) -Pregnancy or lactation -Pregnancy wish
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the pharmacokinetic interaction of elexacaftor/tezacaftor/ivacaftor and tacrolimus in adult CF patients using tacrolimus after renal or liver transplantation by: - quantitating the effect of elexacaftor/tezacaftor/ivacaftor on the bioavailability of tacrolimus in CF patients with a history of liver or kidney transplantation and current on tacrolimus treatment. - quantitating the dose adjustment of tacrolimus during co-administration of elexacaftor/tezacaftor/ivacaftor. ;Secondary Objective: - To investigate the clinical effect of elexacaftor/tezacaftor/ivacaftor in CF patients using tacrolimus after renal or liver transplantation. - To quantitate the exposure to elexacaftor/tezacafor/ivacaftor in week 1, 2, 3 and 4 after starting elexacaftor/tezacaftor/ivacaftor. - To quantitate the number of side effects (adverse events and serious adverse events) when when co-administrating the elexacftor/tezacaftor/ivacaftor with tacrolimus. ;Primary end point(s): - Pharmacokinetic parameters: T1/2, Tmax, Cmax, Cmin, AUC all measured without and with co administration of elexacaftor/tezacaftor/ivacaftor in order to measure RAUC of tacrolimus (RAUC=AUCtacro with elexacaftor/tezacaftor/ivacaftor/AUCtacro) in week 1, 2, 3 and 4 after starting elexacaftor/tezacaftor/ivacaftor. Change in T1/2, Tmax, Cmax, Cmin after co-administration with elexacaftor/tezacaftor/ivacaftor measured in week 1, 2, 3 and 4 after starting elexacaftor/tezacaftor/ivacaftor. - Number and level of dose adjustments made in order to stay within target tacrolimus values. ;Timepoint(s) of evaluation of this end point: at the end of the study period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Absolute change in lung function (FVC and FEV1), absolute change in quality of life (CFQ), , absolute change in nutritional status (weight, BMI) in week 1, 2, 3 and 4 after starting elexacaftor/tezacaftor/ivacaftor. Absolute change in sweatchloride from baseline through end of the study. - Through concentrations of elexacaftor, tezacaftor and ivacaftor measured in week 1, 2, 3 and 4 after starting elexacaftor/tezacaftor/ivacaftor. - Safety and tolerability based on the number and type of (S)AEs, laboratory values and vital signs. ;Timepoint(s) of evaluation of this end point: at the end of the study period | — |
Countries
Netherlands
Contacts
Public ContactDept of pulmonology and CF
Haga Teaching Hospital
Outcome results
None listed