N/A
ID
Bron
Verkorte titel
Aandoening
Kidney transplantation
Ondersteuning
P.Debyelaan 25,
NL-6229 HX Maastricht
Phone: (+31) 43 3875007
Fax: (+31) 43 3875006
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Evaluation and comparison of the intra- and interpatient variability for the area under the curve (AUC) of orally administered Tac BID and Tac QD.
Achtergrond van het onderzoek
A modified-release formulation of Tacrolimus, a potent immuno-suppressor, has been developed which has to be taken once daily (Tac QD, Advagrafâ) instead of twice daily as is the case with the immediate-release formulation (Tac BID, Prografâ). 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).
Doel van het onderzoek
N/A
Onderzoeksopzet
Weekly 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.
Onderzoeksproduct en/of interventie
Conversion from tacrolimus twice daily (TAC BID) to tacrolimus once daily (TAC QD).
Algemeen / deelnemers
Maastricht University Medical Centre, Dept of Internal Medicine, Division of Nephrology,
P.Debyelaan 25,
Maastricht 6229 HX
The Netherlands
+31 (0)43 3875007
F.Stifft@MUMC.nl
Wetenschappers
Maastricht University Medical Centre, Dept of Internal Medicine, Division of Nephrology,
P.Debyelaan 25,
Maastricht 6229 HX
The Netherlands
+31 (0)43 3875007
F.Stifft@MUMC.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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 SNP’s (carrier or homozygous for *1) to ensure inclusion of an adequate amount of patients with an increased metabolism of tacrolimus.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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).
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1690 |
| NTR-old | NTR1791 |
| CCMO | NL26976.068.09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |
| OMON | NL-OMON35391 |