Kidney Graft Tolerance KTOL (KTOL)

April 29, 2026 updated by: Nantes University Hospital

Non-interventional Single-center Study of the Contribution of DP8α Regulatory T Cells Induced by a Gut Microbiota Bacterium to Kidney Transplant Tolerance.

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44093

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will use PBMCs from 15 patients receiving a kidney transplant from a living, ABO-compatible donor from their family or acquaintance. These PBMC will be obtained from blood samples taken before and 3 months after transplantation, in the context of normal patient management. The study will also use PBMC from the donor, taken before the transplant.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Donor patients
Recipient patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2024

Primary Completion (Estimated)

August 22, 2027

Study Completion (Estimated)

August 22, 2027

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Actual)

February 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RC23_0394

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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