Kidney Transplantation
Conditions
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.
Interventions
OTHERRegulatory T cells
Single infusion of expanded regulatory T cells.
DRUGTocilizumab
Treatment during first month post-transplant.
OTHERBone marrow
Infusion of donor bone marrow cells.
PROCEDUREKidney transplant
Living donor kidney transplantation.
OTHERImmunosuppressive drug therapy
Immunosuppressive drug therapy.
Sponsors
Thomas Wekerle
University Hospital Regensburg
Div. of Nephrology and Dialysis, Medical University of Vienna
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety measured as GVHD (graft-versus-host disease), impaired graft function or patient death | 12 months | Incidence of composite safety endpoint by 12 months post-transplant. |
| Chimerism | 1 month | Total leukocyte donor chimerism in blood. |
Countries
Austria
Contacts
PRINCIPAL_INVESTIGATORThomas Wekerle, MD
Medical University of Vienna
Outcome results
None listed