Personalized Use of Resources study

Recruiting

Conditions: immunosuppression after kidney transplant with CYP3A*5 genotyping
preventing rejection kidney after transplant when having a diversion in the CYP3A5 gene.
10038430
10038365

Registration Number: NL-OMON54135

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 25

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<5%) with therapeutic tacrolimus
concentrations between 4-9 ng/L and on a stable tacrolimus dose (are using the
same dosage of Tacrolimus extended release for the last month) with
Tacrolimus-Extended-Release with a C/D ratio < 1.05 ng/mL×1/mg
c. Patients must provide written informed consent
d. Patients of childbearing potential must agree to use highly effective
methods of contraception during the study.

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The dose in mg of Tacrolimus-LCPT (Envarsus) needed to reach adequate levels of<br /><br>tacrolimus trough levels in comparison with Tacrolimus-Extended-Release<br /><br>(Advagraf).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are:<br /><br>- variability of trough levels;<br /><br>- pill burden<br /><br>- Cmax and Tmax;<br /><br>- C/D ratio<br /><br>- 24hour AUC levels;<br /><br>- side effects;<br /><br>- CYP3A5 genotypes.</p><br>