Tacrolimus Pharmacokinetic Subpopulations

Condition(s) studied

Investigational drug(s) / intervention(s)

Dosage Forms Oral: Dosage form of tacrolimus (extended release tacrolimus or immediate release tacrolimus)

Study summary

This prospective study will investigate the concentrations of tacrolimus metabolites (M-I and M-III) over the four first years post-transplantation.

A differential metabolism might result in different metabolites' concentration and explain a kidney survival difference between "high rate metabolism" (defined as a concentration/dose ratio, C/D ratio, lower than 1.04 µg/l/mg) and other patients.

The primary endpoint is therefore to compare tacrolimus metabolites' concentrations with respect to the group, either \< or \>= 1.04 µg/l/mg, in order to detect differences in tacrolimus metabolization between these groups.

Eligibility

Primary outcome measure(s)

• Tacrolimus metabolite concentration — month 3
  The concentration of tacrolimus metabolites M-I and M-III will be evaluated by liquid chromatography / tandem mass spectrometry (LC-MS/MS) given in micrograms per litre (μg/l).
• Genotyping — Enrollment
  Genotypes of target genes involved in tacrolimus metabolism (CYP450 3A5, CYP450 3A4, ABCB1)
• Tacrolimus residual concentration — month 3
  In addition to the Tacrolimus residual concentration assessed at each visit, this measure will also be performed at T0, T+1h and T+3h for immediate-release tacrolimus and T0, T+1h and T+8h for prolonged-release tacrolimus after treatment. The measurement at T+8h will be carried out on blotting paper with a drop of capillary blood which will be returned by mail, using an envelope given to the patient during the visit. These three measuring points will be used to identify the abbreviated kinetics of tacrolimus during M3 visit.

Trial sites (2)

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