Nantes University Hospital
Nantes, Loire-Atlantique, 44093, France
Location status: Recruiting
Recruiting
NCT Number: NCT06271343
Kidney Graft Tolerance KTOL
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
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To test the role of donor-specific DP8α Tregs in preventing kidney transplant rejection.
Time frame: 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 outcomes
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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
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.
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Determine whether clones of DP8α Tregs (reactive or not to donor antigens) are reactive to F. prausnitzii bacteria.
Time frame: 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Nantes University Hospital
Other
Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
Registry information
Official study title
Non-interventional Single-center Study of the Contribution of DP8α Regulatory T Cells Induced by a Gut Microbiota Bacterium to Kidney Transplant Tolerance.
Acronym: KTOL
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Feb 21, 2024
- Registry last updated
- May 5, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.