Kidney Transplant ToleranceKTOLNCT06271343
Kidney Graft Tolerance KTOL
An observational study of Kidney Transplant Tolerance, run by Nantes University Hospital at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Tolerance
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 14 May 2024to 22 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Donor/recipient ABO incompatibility
- BMI > 35 for recipients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Nantes University Hospital
Nantes, Loire-Atlantique, 44093
Christophe MASSET, PH, 33 2 76 64 39 61, christophe.masset@chu-nantes.fr
About this study
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.
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.
- Conditions
- Kidney Transplant Tolerance
- Keywords
- DP8 Regulatory Lymphocytes, Intestinal Microbiota, Tolerance, Transplant, Kidney
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Donor patients | Not described | |
| Recipient patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test the role of donor-specific DP8α Tregs in preventing kidney transplant rejection.
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.
Measured: 3 months
Secondary outcomes (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.
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.
Measured: 3 months
Determine whether clones of DP8α Tregs (reactive or not to donor antigens) are reactive to F. prausnitzii bacteria.
The response (proliferation or cytokine secretion) of donor-reactive DP8α Tregs clones will be tested against patient monocytes loaded with F. prausnitzii bacteria.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start14 May 2024
- Primary completion22 Aug 2027 (estimated)
- Study completion22 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271343
- Sponsor's protocol ID
- RC23_0394
- Acronym
- KTOL
- Status last verified
- Apr 2026
- First submitted
- 14 Feb 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06271343
- Acronym / sponsor ID
- KTOL / RC23_0394
- Conditions
- Kidney Transplant Tolerance
- Keywords
- DP8 Regulatory Lymphocytes, Intestinal Microbiota, Tolerance, Transplant, Kidney
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 14 May 2024 (actual)
- Primary completion
- 22 Aug 2027 (estimated)
- Study completion
- 22 Aug 2027 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donor patients | – | – |
| Recipient patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Donor/recipient ABO incompatibility
- BMI > 35 for recipients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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Tolerance Through Mixed Chimerism (Sip-Tego)
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TLI, TBI, ATG & Hematopoietic Stem Cell Transplantation and Recipient T Regs Therapy in Living Donor Kidney Transplantation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Tolerance, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe MASSET, PH (33 2 76 64 39 61, christophe.masset@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To test the role of donor-specific DP8α Tregs in preventing kidney transplant rejection. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.