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Tacrolimus Pharmacokinetic Subpopulations

ConditionsKidney Transplant Failure and RejectionImmunosuppression-related Infectious Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Grenoble

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Kidney transplant patients at the CHUGA, CHU Saint-Etienne or CHU Clermont-Ferrand, whose new transplant is no more than 7 days old (inclusive)

Patients initially treated with tacrolimus as an immunosuppressant, combined with mycophenolate (MMF), mycophenolic acid (MPA) or everolimus (EVR), with or without corticotherapy.

No plans to remove tacrolimus from the patient's immunosuppressive treatment (e.g. no plans to switch to belatacept a priori), during the first 4 years post-transplantation.

Affiliation to or beneficiary of a social security scheme

Disqualifiers

Contraindication to the use of tacrolimus

Patient already treated with tacrolimus at the time of transplantation

Pregnant, parturient or breastfeeding women

Patient deprived of liberty by judicial or administrative decision

Trial population

The study population is made of kidney transplant patients with living or deceased donors at Grenoble University Hospital, Saint Etienne University Hospital or Clermont-Ferrand University Hospital.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Dosage Forms Oral

    Drug

    Dosage form of tacrolimus (extended release tacrolimus or immediate release tacrolimus)

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Tacrolimus once-daily1 intervention
Group B: Tacrolimus bid1 intervention

Trial outcomes

Primary outcomes

1

Tacrolimus metabolite concentration

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).

Time frame
month 3
2

Genotyping

Genotypes of target genes involved in tacrolimus metabolism (CYP450 3A5, CYP450 3A4, ABCB1)

Time frame
Enrollment
3

Tacrolimus residual concentration

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.

Time frame
month 3

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Grenoble

Lead sponsor

Chiesi SA/NV

Collaborator

Source ClinicalTrials.gov
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