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Clinical Trials in China / NCT06715865
Starting soon Not applicable

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

NCT06715865 · tracked via the Priya Life Science China tracker
Sponsor
RenJi Hospital
Phase
Not applicable
Started
2025-01
Last updated
2024-12-04

Condition(s) studied

Kidney Transplant

Investigational drug(s) / intervention(s)

Thymus Transplantation

Thymus Transplantation: Thymus Transplantation

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Duration of immunosuppressive therapy after surgery — 2 years

Trial sites (1)

FacilityCityRegionStatus
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality

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Other trials for the same condition

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Efficacy and Safety of Leymovir Versus Valganciclovir in Prevention of Cytomegalovirus Infection and Cytomegalovirus Disease in Chinese Kidney Transplant Recipients Recruiting
A Mixed Cohort, Multicentre Exploratory Study of Non-invasive Quantitative Assessment of Renal Graft Function With Non-contrast Functional Magnetic Resonance Imaging Recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06715865 on ClinicalTrials.gov ↗ ← All trials in China