Kidney TransplantationPhase 1/2NCT03867617
Cell Therapy for Immunomodulation in Kidney Transplantation
A Phase 1/2 study testing Regulatory T cells, Tocilizumab and Bone marrow in people with Kidney Transplantation, run by Thomas Wekerle at 1 site in Austria.
Trial summary
This study investigates treatment with recipient regulatory T cells and donor bone marrow together with tocilizumab for immunomodulation in living donor kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Regulatory T cells, Tocilizumab and Bone marrow
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustria
- Study dates
- 1 Aug 2019to Jun 2028
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has provided written informed consent.
- Patient is 18 years or older.
- Patient is a planned recipient of a living donor kidney transplant.
- Patient is a planned recipient of an ABO blood group-compatible kidney graft.
- Patient is a planned recipient of a kidney graft from a donor that is not HLA (human leukocyte antigen)-identical.
- Patient is negative for DSA (donor-specific antibodies).
- WOCBP (women of child-bearing potential) must have a negative pregnancy test at inclusion.
- WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the study in such a manner that the risk of pregnancy is minimized.
Who cannot join
- Patient is EBV (epstein barr virus)-negative on serology.
- Patient is HIV-positive or suffering from chronic viral hepatitis.
- Patient is CMV (cytomegalo virus)-negative and receiving a kidney from a CMV-positive donor.
- Positive T-cell lymphocytotoxic cross match.
- Patient with prior kidney transplant or non-renal solid organ transplant.
- Patient has a known contraindication to any of the protocol-specified treatments.
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- Patient had been diagnosed with a malignancy within 5 years prior to study entry, excluding non-metastatic basal or squamous cell carcinoma of the skin.
- Female patients who are breast-feeding.
- Female patients with a positive pregnancy test.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna/Vienna General Hospital
Vienna, 1090
About this study
Official title: A Prospective Controlled Trial to Evaluate Safety and Efficacy of in Vitro Expanded Recipient Regulatory T Cell Therapy and Tocilizumab Together With Donor Bone Marrow Infusion in HLA-mismatched Living Donor Kidney Transplant Recipients
This study investigates treatment with recipient regulatory T cells and donor bone marrow together with tocilizumab for immunomodulation in living donor kidney transplant recipients.
- Conditions
- Kidney Transplantation
- Being tested
- Regulatory T cells, Tocilizumab, Bone marrow, Kidney transplant, Immunosuppressive drug therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regulatory T cellsOther
Single infusion of expanded regulatory T cells.
TocilizumabDrug
Treatment during first month post-transplant.
Bone marrowOther
Infusion of donor bone marrow cells.
Kidney transplantProcedure or surgery
Living donor kidney transplantation.
Immunosuppressive drug therapyOther
Immunosuppressive drug therapy.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Treatment with regulatory T cells, donor bone marrow and tocilizumab in addition to immunosuppressive drug therapy in kidney transplant recipients Receives: Other: Regulatory T cells; Drug: Tocilizumab; Other: Bone marrow; Procedure: Kidney transplant; Other: Immunosuppressive drug therapy |
| Control group | Active comparator | Immunosuppressive drug therapy without treatment with regulatory T cells, donor bone marrow and tocilizumab in kidney transplant recipients Receives: Procedure: Kidney transplant; Other: Immunosuppressive drug therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured as GVHD (graft-versus-host disease), impaired graft function or patient death
Incidence of composite safety endpoint by 12 months post-transplant.
Measured: 12 months
Chimerism
Total leukocyte donor chimerism in blood.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start1 Aug 2019
- Primary completion30 Jun 2024
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Wekerle
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Regensburg, Medical University of Vienna
- Responsible party
- Sponsor-investigator, Thomas Wekerle, Medical University of Vienna
- Investigators
- Thomas Wekerle, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867617
- Sponsor's protocol ID
- Trex001
- Status last verified
- Sep 2026
- First submitted
- 6 Mar 2019
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oberbauer R, Edinger M, Berlakovich G, Kalhs P, Worel N, Heinze G, Wolzt M, Lion T, Wekerle T. A Prospective Controlled Trial to Evaluate Safety and Efficacy of in vitro Expanded Recipient Regulatory T Cell Therapy and Tocilizumab Together With Donor Bone Marrow Infusion in HLA-Mismatched Living Donor Kidney Transplant Recipients (Trex001). Front Med (Lausanne). 2021 Jan 27;7:634260. doi: 10.3389/fmed.2020.634260. eCollection 2020.
PubMed 33585521
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Controlled Trial to Evaluate Safety and Efficacy of in Vitro Expanded Recipient Regulatory T Cell Therapy and Tocilizumab Together With Donor Bone Marrow Infusion in HLA-mismatched Living Donor Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT03867617
- Acronym / sponsor ID
- Trex001
- Conditions
- Kidney Transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Thomas WekerleUniversity, hospital or other
- Collaborators
- University Hospital Regensburg, Medical University of Vienna
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- Jun 2028 (estimated)
- First posted
- 8 Mar 2019 (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.
This study investigates treatment with recipient regulatory T cells and donor bone marrow together with tocilizumab for immunomodulation in living donor kidney transplant recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Regulatory T cells, Drug: Tocilizumab, Other: Bone marrow, Procedure: Kidney transplant, Other: Immunosuppressive drug therapyTreatment with regulatory T cells, donor bone marrow and tocilizumab in addition to immunosuppressive drug therapy in kidney transplant recipients |
| Control group | Active comparator | Procedure: Kidney transplant, Other: Immunosuppressive drug therapyImmunosuppressive drug therapy without treatment with regulatory T cells, donor bone marrow and tocilizumab in kidney transplant recipients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient has provided written informed consent.
- Patient is 18 years or older.
- Patient is a planned recipient of a living donor kidney transplant.
- Patient is a planned recipient of an ABO blood group-compatible kidney graft.
- Patient is a planned recipient of a kidney graft from a donor that is not HLA (human leukocyte antigen)-identical.
Key exclusion criteria (9 listed)
- Patient is EBV (epstein barr virus)-negative on serology.
- Patient is HIV-positive or suffering from chronic viral hepatitis.
- Patient is CMV (cytomegalo virus)-negative and receiving a kidney from a CMV-positive donor.
- Positive T-cell lymphocytotoxic cross match.
- Patient with prior kidney transplant or non-renal solid organ transplant.
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 |
|---|---|---|
| Regulatory T cellsSingle infusion of expanded regulatory T cells. | Other | Study group |
| TocilizumabTreatment during first month post-transplant. | Drug | Study group |
| Bone marrowInfusion of donor bone marrow cells. | Other | Study group |
| Kidney transplantLiving donor kidney transplantation. | Procedure or surgery | Control group, Study group |
| Immunosuppressive drug therapyImmunosuppressive drug therapy. | Other | Control group, Study group |
Primary outcome
Safety measured as GVHD (graft-versus-host disease), impaired graft function or patient death
Time frame: 12 months
Incidence of composite safety endpoint by 12 months post-transplant.
Chimerism
Time frame: 1 month
Total leukocyte donor chimerism in blood.
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 11 Sep 2026.
- Derived from this study: PubMed 33585521Oberbauer R, Edinger M, Berlakovich G, Kalhs P, Worel N, Heinze G, Wolzt M, Lion T, Wekerle T. A Prospective Controlled Trial to Evaluate Safety and Efficacy of in vitro Expanded Recipient Regulatory T Cell Therapy and Tocilizumab Together With Donor Bone Marrow Infusion in HLA-Mismatched Living Donor Kidney Transplant Recipients (Trex001). Front Med (Lausanne). 2021 Jan 27;7:634260. doi: 10.3389/fmed.2020.634260. eCollection 2020.
- Individual participant dataSharing planned: No
Related trials for Kidney Transplantation
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Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
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Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant
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A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
Active, not recruitingPhase 2
Sequential Daratumumab Followed by Telitacicept for the Treatment of ABMR After Kidney Transplantation-A Phase IIa Clinical Trial
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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. This study is not recruiting at the moment.
Thomas Wekerle, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Regulatory T cells, Tocilizumab and Bone marrow in people with Kidney Transplantation, run by Thomas Wekerle at 1 site in Austria.
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 8 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. 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 Austria. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety measured as GVHD (graft-versus-host disease), impaired graft function or patient death (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03867617, which also lists 1 linked publication.
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 11 Sep 2026.