Clinical Study on Thymus-Kidney Transplantation From Neonatal Donors for the Induction of Immune Tolerance

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Kidney Transplant

Treatments: Procedure: Thymus Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT06715865

LY2024-248-B

Details and patient eligibility

About

Thymus transplantation for the induction of immune tolerance in kidney transplantation: This study aims to understand how thymus transplantation can induce immune tolerance in recipients of allogeneic kidney transplants to achieve the discontinuation of immunosuppressive therapy. It will evaluate the safety of thymus transplantation, explore the functional output of thymus tissue, investigate the optimal timing for withdrawal of immunosuppressants, and identify key indicators for the reconstruction of immune suppression capacity.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Recipients of both thymus and kidney transplants from the same donor.
2. Age between 18 and 65 years.
3. Non-solid organ combination transplant recipients (including heart-kidney or liver-kidney transplants, except thymus).
4. ABO blood type compatibility with the donor.
5. Negative donor-specific antibody (DSA).
6. Negative lymphocyte crossmatch (CDC).
7. Normal cardiac function (confirmed through ECG and echocardiograms).
8. Normal liver function.
9. Bodyweight between 40-100 kg (inclusive).
10. Evidence of prior epstein-barr virus (EBV) infection with positive EBV-specific immunoglobulin G (IgG) and negative immunoglobulin M (IgM).
11. Signed informed consent form.
12. Ability to adhere to regular follow-ups.
13. Normal hematopoietic function.

Exclusion criteria

1. Clinically significant genital or urinary tract dysfunction.

2. Underlying kidney diseases with a high risk of recurrence in the transplanted kidney, including:

   • a. Focal segmental glomerulosclerosis (FSGS).
   • b. Type I or II membranoproliferative glomerulonephritis.
   • c. Hemolytic uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP).

3. Any genetic mutation-associated diseases.

4. Presence of infectious diseases:

5. Strongly positive panel reactive antibodies (PRA).

6. History of receiving blood transfusion therapy.

7. Any other conditions that, in the investigator's opinion, are incompatible with participation in the trial.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Thymus Transplantation Group

Experimental group

Treatment:

Procedure: Thymus Transplantation