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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06715865

Enrollment

Registered

2024-12-04

Start date

2025-01-31

Completion date

2027-12-31

Last updated

2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant

Brief summary

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.

Interventions

PROCEDUREThymus Transplantation

Thymus Transplantation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
Duration of immunosuppressive therapy after surgery	2 years

Countries

China

Contacts

Primary ContactZhang Ming

drmingzhang@126.com13817817827

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026