The TOMATO Study (Tacrolimus Metabolization in Kidney Transplantation): Impact of the Concentration-Dose Ratio on Death-censored Graft Survival.
Thomas Jouve, Xavier Fonrose, Johan Noble...
https://pubmed.ncbi.nlm.nih.gov/31415035Actively Recruiting
Age: 18Years +
All Genders
ID04526431
Tacrolimus Pharmacokinetic Subpopulations: Prospective Mechanistic Investigations of the Tacrolimus C/D Ratio
Led by University Hospital, Grenoble · Updated on 2021-02-10
180
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Grenoble
Lead Sponsor
C
Chiesi SA/NV
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how the body processes tacrolimus, a key immunosuppressive drug used after kidney transplantation. This study focuses on understanding differences in tacrolimus metabolism by measuring specific metabolites and analyzing genetic factors. The goal is to explain why some patients, identified by a lower concentration-to-dose ratio, may have different kidney transplant survival outcomes compared to others. Participants will be randomly assigned to receive tacrolimus either as a once-daily prolonged-release form or as a twice-daily immediate-release form. The study will follow these patients for four years after their kidney transplant. During this time, regular visits will include biological tests, adherence questionnaires, kidney biopsies at specific months, and pharmacokinetic studies to monitor tacrolimus exposure. Throughout the study, participants will undergo consultations at 6 weeks, 3, 6, 12, 24, 36, and 48 months post-transplant. Evaluations include blood tests, genetic analysis at enrollment, and measuring tacrolimus metabolite and residual concentrations at 3 months. Researchers will assess how metabolism differences relate to kidney transplant outcomes while monitoring patient safety and treatment adherence over the four-year period.
CONDITIONS
Brief Title
Tacrolimus Pharmacokinetic Subpopulations
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 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 during the first 4 years post-transplantation
- Affiliation to or beneficiary of a social security scheme
- Able to read and understand the terms of the protocol
- Informed consent obtained, including specific consent for genetic analysis of target genes
- For women of childbearing potential, presence of effective contraception (already acquired for patients treated with mycophenolic acid as an immunosuppressant)
You will not qualify if you...
- 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
- Patient under guardianship or curatorship, or receiving forced psychiatric care
- Person admitted to a health or social institution
- Subject cannot be contacted in case of emergency
- Subject in period of exclusion from another study
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - Up to 7 days after transplantation
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Treatment
Duration - 4 years
Participants receive tacrolimus immunosuppression as either a once-daily or twice-daily oral formulation and are monitored to identify metabolism patterns and determinants of tacrolimus pharmacokinetics.
Regular visits at Week 6, Month 3, Month 6, Month 12, Month 24, Month 36, and Month 48
Monitoring
Duration - 4 years (concurrent with treatment visits)
Participants undergo regular biological analyses, renal transplant biopsies, pharmacokinetic studies, and adherence questionnaires to assess tacrolimus exposure and transplant health.
Biopsies at Month 3 and Month 12; pharmacokinetic study at Month 3; adherence questionnaires and biological analyses at each visit
Trial Site Locations
Total: 2 locations
1
Grenoble University Hospital
Grenoble, Auvergne-Rhône-Alpes, France, 38043
Actively Recruiting
2
Saint Etienne University Hospital
Saint-Etienne, Auvergne-Rhône-Alpes, France, 42000
Not Yet Recruiting
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Research Team
T
Thomas JOUVE, MD, PhD
J
Johan NOBLE, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
An update on the safety of tacrolimus in kidney transplant recipients, with a focus on tacrolimus minimization.
Thomas Jouve, Johan Noble, Lionel Rostaing...
https://pubmed.ncbi.nlm.nih.gov/30909754The tacrolimus metabolism rate influences renal function after kidney transplantation.
Gerold Thölking, Christian Fortmann, Raphael Koch...
https://pubmed.ncbi.nlm.nih.gov/25340655High Tacrolimus Clearance Is a Risk Factor for Acute Rejection in the Early Phase After Renal Transplantation.
Erlend Johannessen Egeland, Ida Robertsen, Monica Hermann...
https://pubmed.ncbi.nlm.nih.gov/28452920