An open-label, single centre study to assess and compare the intra- and interpatientvariability in the oral bioavailability for Immediate-Release Tacrolimus and after conversion to Modified-Release Tacrolimus in stable kidney transplant recipients.
Completed
- Conditions
- kidney transplantationrenal transplant10046447
- Registration Number
- NL-OMON35391
- Lead Sponsor
- Interne Geneeskunde, onderafdeling Nefrologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
· 18 years of age or older
· stable renal allograft function
· immunosuppression with Tac BID (Prograft)
· part of the population is selected on base of already known CYP3A5 SNP*s (carrier or homozygous for CYP3A5*1) to ensure inclusion of an adequate amount of patients with an increased metabolism of tacrolimus.
Exclusion Criteria
· graft failure
· other organ transplanted than kidney
· malignancy
· renal replacement therapy (RRT)
· sign of infection before inclusion
· patients already taking Tac QD
.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- intra- and interpatientvariability of the Area Under the Curve (AUC) for<br /><br>orally administered Tacrolimus.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- tacrolimus maximum concentration (Cmax) and its intra- and<br /><br>interpatientvariability;<br /><br>- time to reach Cmax (Tmax) and its intra- and interpatientvariability;<br /><br>- tacrolimus trough level (Cmin) and its intra- and interpatientvariability;<br /><br>- CYP3A5 genotype;<br /><br>- questionnaires on health status and quality of life<br /><br>- transplant function (endogeneous creatinine clearance<br /><br>- use of co-medication<br /><br>- the change in tacrolimus bloodlevels (AUC) when Advagraf is administered<br /><br>together with a continental breakfastI (only patients participating in<br /><br>amendment 2 (AUC tacrolimus intake together with breakfast) </p><br>