kidney failure werefor need for kidney transplant
Conditions
Brief summary
The objective is to evaluate if the LCPT dose can be reduced in comparison with tacrolimus-ER and still achieve similar tacrolimus levels in the therapeutic range in patients who have a C/D ratio < 1.05 ng/mL×1/mg.
Detailed description
To evaluate if the switch design of the study leads to a lower pill burden; - to evaluate if the LCPT switch leads to less side effects; - to evaluate if the LCPT switch leads to less variability in trough levels; - to evaluate if patients with CYP3A5*1 allele is a factor to consider when prescribing tacrolimus variants; and - to evaluate differences in Cmax, Tmax and 24hour AUC levels.
Interventions
Sponsors
Stichting Amsterdam UMC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective is to evaluate if the LCPT dose can be reduced in comparison with tacrolimus-ER and still achieve similar tacrolimus levels in the therapeutic range in patients who have a C/D ratio < 1.05 ng/mL×1/mg. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate if the switch design of the study leads to a lower pill burden; - to evaluate if the LCPT switch leads to less side effects; - to evaluate if the LCPT switch leads to less variability in trough levels; - to evaluate if patients with CYP3A5*1 allele is a factor to consider when prescribing tacrolimus variants; and - to evaluate differences in Cmax, Tmax and 24hour AUC levels. | — |
Countries
Netherlands
Outcome results
None listed