Clinical Study on Thymus-Kidney Transplantation From Neonatal Donors for the Induction of Immune Tolerance
NCT ID: NCT06715865
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
10 participants
INTERVENTIONAL
2025-01-31
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Thymus Transplantation Group
Thymus Transplantation
Thymus Transplantation
Interventions
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Thymus Transplantation
Thymus Transplantation
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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RenJi Hospital
OTHER
Responsible Party
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Locations
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Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Zhang Ming
Role: primary
Other Identifiers
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LY2024-248-B
Identifier Type: -
Identifier Source: org_study_id