Renal TransplantationPhase 2NCT05086003
Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction
A Phase 2 study testing Combined kidney and bone marrow transplantation in people with Renal Transplantation, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Combined transplantation of kidney and bone marrow between HLA-matched sibling donor-recipient pairs to induce immune tolerance in order to enable complete discontinuation of immunosuppressive therapy without kidney rejection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- Combined kidney and bone marrow transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 19 Jan 2016to 31 Dec 2026
- Phase
- Phase 2
- 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
- Age older than 18 years
- Matched siblings
- No contra-indication to thymoglobuline or total lymphoid irradiation
Who cannot join
- Pregnant women or breast feeding
- Infection with HIV, HBV or HCV
- Previous or presnt malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva, 49100
Moshe Yeshurun, 0526015543, moshe.yeshurun@gmail.com
About this study
Official title: Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction Between Matched Sibling Donor-recipient Pairs
Combined transplantation of kidney and bone marrow between HLA-matched sibling donor-recipient pairs to induce immune tolerance in order to enable complete discontinuation of immunosuppressive therapy without kidney rejection. Hematopoietic stem cells are collected from the donor 4 to 8 weeks before kidney transplantation, CD34 cells are enriched by positive selection and cryopreserved. The day after kidney transplantation the recipient starts conditioning therapy with thymoglobuline, total lymphoid irradiation, steroids, tacrolimus and mycophenolate mofetil. Eleven days after kidney transplantation the stem cell graft is thawed and infused to the recipient. If mixed donor chimerism is successfully maintained more than 6 months without rejection, then immunosuppression may be tapered off until complete discontinuation.
- Conditions
- Renal Transplantation
- Being tested
- Combined kidney and bone marrow transplantation
- Keywords
- Renal transplantation, Bone marrow transplantation, Immune tolerance, Immunosuppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined kidney and bone marrow transplantationCombination product
Combined kidney and bone marrow transplantation
| Study group | Role | What they receive |
|---|---|---|
| Kidney and bone marrow transplantation | Experimental | Combined kidney and bone marrow transplantation after preparation with thymoglobuline and total lymphoid irradiation Receives: Combination Product: Combined kidney and bone marrow transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of transplanted patients who were able to discontinue immunosuppression 12 months after transplantation.
Proportion of transplanted patients who were able to discontinue immunosuppression 12 months after transplantation.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start19 Jan 2016
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Combined kidney and bone marrow transplantation
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, moshe yeshurun, Rabin Medical Center
- Investigators
- Moshe Yeshurun, MD, Principal investigator, Institution of Hematology, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086003
- Sponsor's protocol ID
- 0759-15
- Status last verified
- Oct 2021
- First submitted
- 7 Oct 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction Between Matched Sibling Donor-recipient Pairs
- ClinicalTrials.gov ID
- NCT05086003
- Acronym / sponsor ID
- 0759-15
- Conditions
- Renal Transplantation
- Keywords
- Renal transplantation, Bone marrow transplantation, Immune tolerance, Immunosuppression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 19 Jan 2016 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Oct 2021 (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.
Combined transplantation of kidney and bone marrow between HLA-matched sibling donor-recipient pairs to induce immune tolerance in order to enable complete discontinuation of immunosuppressive therapy without kidney rejection. Hematopoietic stem cells are collected from the donor 4 to 8 weeks before kidney transplantation, CD34 cells are enriched by positive selection and cryopreserved. The day after kidney transplantation the recipient starts conditioning therapy with thymoglobuline, total lymphoid irradiation, steroids, tacrolimus and mycophenolate mofetil. Eleven days after kidney transplantation the stem cell graft is thawed and infused to the recipient. If mixed donor chimerism is successfully maintained more than 6 months without rejection, then immunosuppression may be tapered off until complete discontinuation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Combined kidney and bone marrow transplantation
| Arm | Type | Receives |
|---|---|---|
| Kidney and bone marrow transplantation | Experimental | Combination Product: Combined kidney and bone marrow transplantationCombined kidney and bone marrow transplantation after preparation with thymoglobuline and total lymphoid irradiation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age older than 18 years
- Matched siblings
- No contra-indication to thymoglobuline or total lymphoid irradiation
Key exclusion criteria (3 listed)
- Pregnant women or breast feeding
- Infection with HIV, HBV or HCV
- Previous or presnt malignancy
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 |
|---|---|---|
| Combined kidney and bone marrow transplantationCombined kidney and bone marrow transplantation | Combination product | Kidney and bone marrow transplantation |
Primary outcome
Proportion of transplanted patients who were able to discontinue immunosuppression 12 months after transplantation.
Time frame: 12 months
Proportion of transplanted patients who were able to discontinue immunosuppression 12 months after transplantation.
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 28 Oct 2021.
- Individual participant dataSharing planned: No
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Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
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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.
Moshe Yeshurun, MD principal investigator
Institution of Hematology, Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Combined kidney and bone marrow transplantation in people with Renal Transplantation, run by Rabin Medical Center at 1 site in Israel.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 28 Oct 2021. 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 Israel. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Moshe Yeshurun, MD (0526015543, moshe.yeshurun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of transplanted patients who were able to discontinue immunosuppression 12 months after transplantation. (time frame: 12 months). 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 28 Oct 2021.