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Not yet recruiting NCT06715865

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

No phase Interventional Kidney Transplant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Thymus Transplantation.
Who it may be relevant to
Registry conditions: Kidney Transplant. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Procedure Thymus Transplantation
    Thymus Transplantation

Primary outcome measures

  • Duration of immunosuppressive therapy after surgery [Time frame: 2 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai

Identifiers

NCT: NCT06715865 · LY2024-248-B

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗