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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.


- candidate number5681
- NTR NumberNTR1791
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-apr-2009
- Secondary IDsNL26976.068.09 
- Public TitleA 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.
- Scientific TitleAn 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.
- ACRONYMAdvagraf conversion trial
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedRenal transplant
- Inclusion criteria1. Renal transplant recipients that were transplanted at least six month before entry into the study;
2. 18 years of age or older;
3. Stable renal allograft function;
4. Immunosuppression with Tacrolimus twice daily (TAC BID);
5. Part of the population is selected on base of already known CYP3A5 SNPís (carrier or homozygous for *1) to ensure inclusion of an adequate amount of patients with an increased metabolism of tacrolimus.
- Exclusion criteria1. Graft failure;
2. Other organ transplanted than kidney;
3. Malignancy;
4. Renal replacement therapy (RRT);
5. Signs of infection before inclusion;
6. Patients already taking Tacrolimus once daily (TAC QD).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jun-2009
- planned closingdate1-jun-2010
- Target number of participants40
- InterventionsConversion from tacrolimus twice daily (TAC BID) to tacrolimus once daily (TAC QD).
- Primary outcomeEvaluation and comparison of the intra- and interpatient variability for the area under the curve (AUC) of orally administered Tac BID and Tac QD.
- Secondary outcome1. Evaluation and comparison of the intra- and interpatient variability for pharmacokinetic parameters:
A. Maximum concentration of tacrolimus (Cmax);
B. Time to reach Cmax (Tmax);
C. Tacrolimus trough levels (Cmin).
2. Correlation of limited sampling strategies (LSS) for Tac BID and Tac QD with a 24-hour AUC;
3. Correlation of pharmacokinetic profiles with CYP3A5 SNPs;
4. Evaluation of the patients perception of Quality of Life (QOL) before and after conversion to a once-daily formulation;
5. Evaluation of the patients perception of the Blood Spot method.
- TimepointsWeekly measurement of the AUC for TAC BID and TAC QD, respectively, during a six week period (i.e. 6 AUCs). The first AUC for TAC QD will be determined two weeks after conversion.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. F. Stifft
- CONTACT for SCIENTIFIC QUERIESDr. M.H.L. Christiaans
- Sponsor/Initiator Maastricht University Medical Centre, Department of Internal Medicine, Division of Nefrology
- Funding
(Source(s) of Monetary or Material Support)
Astellas Pharma B.V
- PublicationsN/A
- Brief summaryA modified-release formulation of Tacrolimus, a potent immuno-suppressor, has been developed which has to be taken once daily (Tac QD, Advagraf‚) instead of twice daily as is the case with the immediate-release formulation (Tac BID, Prograf‚). To our knowledge no numerical data have been published comparing the intra- and interpatient variability of the bioavailability (Area under the curve: AUC) of beforementioned formulations. This study has been designed for this purpose. 40 Stable renal transplant recipients will be converted from TAC BID to TAC QD. For each formulation 6 8-point AUCs will be determined by dried blood spot sampling. Furhtermore the acquired data will be poled towards the patient's cytochrome P 450 3A5 single nucleotide polymorphisms (SNPs).
- Main changes (audit trail)
- RECORD30-apr-2009 - 23-sep-2009


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