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

November 29, 2024 updated by: RenJi Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thymus Transplantation Group
Procedure: Thymus Transplantation
Thymus Transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of immunosuppressive therapy after surgery
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 29, 2024

First Submitted That Met QC Criteria

November 29, 2024

First Posted (Estimated)

December 4, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

November 29, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • LY2024-248-B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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