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

NCT06715865 | Not Yet Recruiting

• 1 other identifier: LY2024-248-B
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant

Outcome Measures

Primary Outcomes (1)

• Duration of immunosuppressive therapy after surgery

  2 years

Study Arms (1)

Thymus Transplantation Group

EXPERIMENTAL

Procedure: Thymus Transplantation

Interventions

Thymus Transplantation PROCEDURE

Thymus Transplantation

Thymus Transplantation Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location

Central Study Contacts

Zhang Ming

CONTACT

13817817827; drmingzhang@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 4, 2024

Record last verified: 2024-11

Locations

CN (1)