Status:
ACTIVE_NOT_RECRUITING
Cell Therapy for Immunomodulation in Kidney Transplantation
Lead Sponsor:
Thomas Wekerle
Collaborating Sponsors:
University Hospital Regensburg
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2028
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03867617
Start Date
August 1 2019
End Date
June 1 2028
Last Update
December 2 2024
Active Locations (1)
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1
Medical University of Vienna/Vienna General Hospital
Vienna, Austria, 1090