Cell Therapy for Immunomodulation in Kidney Transplantation (NCT03867617) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Cell Therapy for Immunomodulation in Kidney Transplantation
Austria12 participantsStarted 2019-08-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Safety measured as GVHD (graft-versus-host disease), impaired graft function or patient death