immunosuppression after kidney transplant with CYP3A*5 genotyping preventing rejection kidney after transplant when having a diversion in the CYP3A5 gene.
Conditions
Interventions
Two treatment arms are used in this study:
- Tacrolimus-Extende-Release (Advagraf)
- Tacrolimus LCPT (Envarsus).
On day 1 the subjects, who are on Advagraf, will be switched to Envarsus in a
rate of 1:0.7 for Advagraf to Envarsus.
Envarsus will then be taken for a period of 3 week
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: a. Patients aged 18 to 70 years, with a stable renal function b. Patients who are at least 6 months until five years after first transplantation, who are not immunized (PRA
Exclusion criteria
Exclusion criteria: a. Patient received or is receiving treatment for acute rejection prior to initiation of study b. Donor Specific antibody positivity and patients who are immunized (PRA>=5%) c. Chronic diarrhoea d. Use of phenytoin, carbamazepine, phenobarbital, primidone, rifampin, caspofungin, erythromycin, clarithromycin, fluconazole, ketoconazole, itraconazole, posaconazole, voriconazole, fluoxetine, fluvozamine, sertraline, venlafaxine, mirtazapine, paroxetine, diltiazem, verapramil, amiodaron e Thyroid dysfunction f. Excessive use of caffeine (more than use of 5 IE daily) g. Excessive use of alcohol (more than 2 IE daily) h.. Patients who are pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The dose in mg of Tacrolimus-LCPT (Envarsus) needed to reach adequate levels of tacrolimus trough levels in comparison with Tacrolimus-Extended-Release (Advagraf). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are: - variability of trough levels; - pill burden - Cmax and Tmax; - C/D ratio - 24hour AUC levels; - side effects; - CYP3A5 genotypes. | — |
Countries
Netherlands
Outcome results
None listed