Kidney Graft Tolerance KTOL
- Conditions
- Kidney Transplant Tolerance
- Registration Number
- NCT06271343
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15
- 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.
- Donor/recipient ABO incompatibility
- BMI > 35 for recipients
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To test the role of donor-specific DP8α Tregs in preventing kidney transplant rejection. 3 months Measurement at D0 and 3 months post-transplant, and comparison, of the frequency of DP8a Tregs expressing CD73 among circulating T lymphocytes and the frequency of donor-reactive DP8a Tregs (identified in culture by their proliferative response to donor monocytes and clonal validation of DP8a Treg anti-donor reactivity at the 3-month post-transplant stage.
- Secondary Outcome Measures
Name Time Method 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. 3 months Sorting of DP8a Tregs from the patient's blood before transplantation (D0) and at 3 months post-transplant, comparison of the TCR repertoire (TRA and TRB) of Tregs between these two stages, by a service provider. Identification (if possible by their Vb) of donor-reactive clones among the amplified TCR clones.
Determine whether clones of DP8α Tregs (reactive or not to donor antigens) are reactive to F. prausnitzii bacteria. 3 months The response (proliferation or cytokine secretion) of donor-reactive DP8α Tregs clones will be tested against patient monocytes loaded with F. prausnitzii bacteria.
Trial Locations
- Locations (1)
Nantes University Hospital
🇫🇷Nantes, Loire-Atlantique, France