Kidney Graft Tolerance KTOL

NCT ID: NCT06271343

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-14

Study Completion Date

2026-06-01

Brief Summary

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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

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Conditions

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Kidney Transplant Tolerance

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Donor patients

No interventions assigned to this group

Recipient patients

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role collaborator

Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nantes University Hospital

Nantes, Loire-Atlantique, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Christophe MASSET, PH

Role: CONTACT

33 2 76 64 39 61

Facility Contacts

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Christophe MASSET, PH

Role: primary

33 2 76 64 39 61

Other Identifiers

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RC23_0394

Identifier Type: -

Identifier Source: org_study_id

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