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A SINGLE-CENTER PHARMACOGENETIC STUDY OF DONOR AND RECIPIENT TO IMPROVE THE EFFICACY AND REDUCE THE NEPHROTOXICITY OF TACROLIMUS AFTER KIDNEY TRANSPLANTATION.


- candidate number7791
- NTR NumberNTR2226
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-feb-2010
- Secondary IDs2010-080 METC Erasmus MC
- Public TitleA SINGLE-CENTER PHARMACOGENETIC STUDY OF DONOR AND RECIPIENT TO IMPROVE THE EFFICACY AND REDUCE THE NEPHROTOXICITY OF TACROLIMUS AFTER KIDNEY TRANSPLANTATION.
- Scientific TitleA SINGLE-CENTER PHARMACOGENETIC STUDY OF DONOR AND RECIPIENT TO IMPROVE THE EFFICACY AND REDUCE THE NEPHROTOXICITY OF TACROLIMUS AFTER KIDNEY TRANSPLANTATION.
- ACRONYMCYP3A5 for dosing tacrolimus
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedRenal transplant
- Inclusion criteriaAdult recipients (18 years or older) who are to receive an ABO-compatible single-organ kidney transplant from a living donor (related or unrelated) will be eligible for entry into the study.
- Exclusion criteriaPatients receiving immunosuppressive therapy (except steroid treatment) within the preceding 28 days except for pretransplant immunosuppressive medication (up to 48 hr before transplantation) will not be included. In addition, patients using medication known to have a pharmacokinetic interaction with tacrolimus will not be asked to participate in the study.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2010
- planned closingdate1-apr-2013
- Target number of participants250
- InterventionsPatients in the standard tacrolimus dose group will receive a dose of 0.20 mg tacrolimus/kg bodyweight per day in two equally divided doses. Patients in the CYP3A5 dosing group will receive a tacrolimus dose of 0.30 mg/kg per day in two equally divided doses if they express CYP3A5 (carriers of the CYP3A5*1 allele) or will receive a tacrolimus dose of 0.15 mg/kg bodyweight in two equally divided doses if they are CYP3A5 non-expressers (CYP3A5*3 allele homozygotes). The tacrolimus dose will be adjusted according to pre-dose concentrations (C0) aiming for target concentrations of 10-15 ng/mL in weeks 1-2, 8-12 ng/mL in weeks 3 and 4 and 5-10 ng/mL thereafter.

All patients will undergo protocol biopsies at t = 0 (pre-implantation biopsy) and at 3 months after transplantation. The pre-implantation biopsy is routinely performed in all patients. The biopsy at 3 months is taken as part of the study protocol.
- Primary outcomeThe primary endpoint of the study is the proportion of patients reaching target levels (10-15 ng/ml) on day 3 and day 7 after transplantation.
- Secondary outcomeSecondary endpoints are the incidence of biopsy-proven acute rejection (BPAR) within the first three months after transplantation and renal function at three months after transplantation.
- TimepointsTime frame: three months.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. T. Gelder, van
- CONTACT for SCIENTIFIC QUERIESDr. T. Gelder, van
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsN/A
- Brief summaryThe aims of the current study are two-fold. First we will investigate whether a CYP3A5 genotype-based tacrolimus dosing strategy will result in improved clinical outcomes as compared with a standard tacrolimus dosing regimen based on bodyweight. Second, we will investigate if ABCB1 and CYP3A5 and single-nucleotide polymorphisms (SNPs) in their encoding genes are associated with the development of tacrolimus-induced nephrotoxicity after kidney transplantation.
- Main changes (audit trail)
- RECORD25-feb-2010 - 9-apr-2010


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