Kidney TransplantNCT06715865
Clinical Study on Thymus-Kidney Transplantation From Neonatal Donors for the Induction of Immune Tolerance
A study testing Thymus Transplantation in people with Kidney Transplant, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- Thymus Transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Jan 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000
Zhang Ming, 13817817827, drmingzhang@126.com
About this study
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
- Being tested
- Thymus Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thymus TransplantationProcedure or surgery
Thymus Transplantation
| Study group | Role | What they receive |
|---|---|---|
| Thymus Transplantation Group | Experimental | Not described Receives: Procedure: Thymus Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of immunosuppressive therapy after surgery
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study startJan 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715865
- Sponsor's protocol ID
- LY2024-248-B
- Status last verified
- Nov 2024
- First submitted
- 29 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Thymus-Kidney Transplantation From Neonatal Donors for the Induction of Immune Tolerance
- ClinicalTrials.gov ID
- NCT06715865
- Acronym / sponsor ID
- LY2024-248-B
- Conditions
- Kidney Transplant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thymus Transplantation Group | Experimental | Procedure: Thymus Transplantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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).
Key exclusion criteria (10 listed)
- Clinically significant genital or urinary tract dysfunction.
- Underlying kidney diseases with a high risk of recurrence in the transplanted kidney, including:
- Any genetic mutation-associated diseases.
- Presence of infectious diseases:
- Strongly positive panel reactive antibodies (PRA).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thymus TransplantationThymus Transplantation | Procedure or surgery | Thymus Transplantation Group |
Primary outcome
Duration of immunosuppressive therapy after surgery
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thymus Transplantation in people with Kidney Transplant, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhang Ming (13817817827, drmingzhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of immunosuppressive therapy after surgery (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.