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
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.
Show all 9Show fewer
- 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