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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03867617
Other study ID # Trex001
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date August 1, 2019
Est. completion date June 2029

Study information

Verified date November 2023
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 12
Est. completion date June 2029
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Regulatory T cells
Single infusion of expanded regulatory T cells.
Drug:
Tocilizumab
Treatment during first month post-transplant.
Other:
Bone marrow
Infusion of donor bone marrow cells.
Procedure:
Kidney transplant
Living donor kidney transplantation.
Other:
Immunosuppressive drug therapy
Immunosuppressive drug therapy.

Locations

Country Name City State
Austria Medical University of Vienna/Vienna General Hospital Vienna

Sponsors (2)

Lead Sponsor Collaborator
Thomas Wekerle University Hospital Regensburg

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety measured as GVHD (graft-versus-host disease), impaired graft function or patient death Incidence of composite safety endpoint by 12 months post-transplant. 12 months
Primary Chimerism Total leukocyte donor chimerism in blood. 1 month
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