Kidney Graft Tolerance KTOL
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Kidney Transplant Tolerance. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Non-interventional Single-center Study of the Contribution of DP8α Regulatory T Cells Induced by a Gut Microbiota Bacterium to Kidney Transplant Tolerance.
Overview
Prospective experimental study using PBMC from a limited number of adult patients (15) treated at Nantes University Hospital for a kidney transplant from a related living donor. The study will be carried out on PBMC from both donors and recipients, collected during visits scheduled as part of the clinical management of the donor/recipient pair. The study will test the hypothesis that DP8α Tregs expressing CD73, whose frequency in blood increases stably after non-rejected kidney transplants, but not when patients have undergone or will subsequently undergo rejection, are enriched in donor-specific cells, which would be a strong argument in favor of a direct role for these Tregs in preventing transplant rejection, through their ability to inhibit immune responses directed against donor alloantigens.
Primary outcome measures
- To test the role of donor-specific DP8α Tregs in preventing kidney transplant rejection. [Time frame: 3 months]
Secondary outcome measures (2)
- Determine whether the increased anti-donor reactivity of the patient's DP8α Tregs after transplantation results from the amplification among them of clones and establish, if possible, the anti-donor reactivity of amplified clones. [Time frame: 3 months]
- Determine whether clones of DP8α Tregs (reactive or not to donor antigens) are reactive to F. prausnitzii bacteria. [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- Adult donor-recipient pair.
- First or second kidney transplant from a related ABO-compatible living donor.
- BMI < 35 for recipients.
- Adult patients.
- Patients weighing over 50 kgs.
Exclusion criteria
- Donor/recipient ABO incompatibility
- BMI > 35 for recipients
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
France · 1 center
- Nantes University Hospital — Nantes
Identifiers
NCT: NCT06271343 · RC23_0394