A study to assess and compare the variation of tacrolimus availability within and bewteen patients when taking an immediate-relase formulation of tacrolimus and after conversion to a formulation with prolonged release.
- Conditions
- Kidney transplantation
- Registration Number
- NL-OMON29529
- Lead Sponsor
- Maastricht University Medical Centre, Dept of Internal Medicine, Division of Nephrology,P.Debyelaan 25, NL-6229 HX MaastrichtPhone: (+31) 43 3875007Fax: (+31) 43 3875006
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
1. Renal transplant recipients that were transplanted at least six month before entry into the study;
2. 18 years of age or older;
Exclusion Criteria
1. Graft failure;
2. Other organ transplanted than kidney;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation and comparison of the intra- and interpatient variability for the area under the curve (AUC) of orally administered Tac BID and Tac QD.
- Secondary Outcome Measures
Name Time Method 1. Evaluation and comparison of the intra- and interpatient variability for pharmacokinetic parameters:<br /><br>A. Maximum concentration of tacrolimus (Cmax);<br /> <br>B. Time to reach Cmax (Tmax);<br /><br>C. Tacrolimus trough levels (Cmin).<br /><br>2. Correlation of limited sampling strategies (LSS) for Tac BID and Tac QD with a 24-hour AUC;<br /><br>3. Correlation of pharmacokinetic profiles with CYP3A5 SNPs;<br /><br>4. Evaluation of the patients perception of Quality of Life (QOL) before and after conversion to a once-daily formulation;<br /><br>5. Evaluation of the patients perception of the Blood Spot method.<br>