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NCT Number: NCT06715865

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

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.

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Key information

Conditions

Kidney Transplant

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location contact

Zhang Ming

CONTACT

[email protected]

13817817827

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Clinically significant genital or urinary tract dysfunction.
  • 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).
  • Any genetic mutation-associated diseases.
  • Presence of infectious diseases:
  • Strongly positive panel reactive antibodies (PRA).
  • History of receiving blood transfusion therapy.
  • Any other conditions that, in the investigator's opinion, are incompatible with participation in the trial.

Treatment and study plan

Thymus Transplantation

Procedure

Thymus Transplantation

Primary outcomes

  1. Duration of immunosuppressive therapy after surgery

    Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Zhang Ming

CONTACT

[email protected]

13817817827

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 4, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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