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 (Trex)

Kidney transplantation

Co-primary endpoint 1 (safety) is defined as incidence of GVHD, impaired graft function [eGFR <35mL/min/1.73m2] or patient death, whichever occurs first, within 12 months post-transplant., Co-primary endpoint 2 (efficacy) is defined as the individual peak chimerism levels within the first month post-transplant.

To demonstrate that the study protocol allows the initiation of a step-wise reduction of immunosuppression up to a point when patients receive drug monotherapy., To gain insight as to whether the study protocol leads to detectable changes in the immune system indicative of pro-tolerogenic immune modulation., To assess the frequency of biopsy-proven acute rejection episodes., To assess the frequency of subclinical rejection episodes on surveillance biopsies., To assess kidney graft function., To assess the area-under-the-curve (AUC) of chimerism.

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Austria