standard immunosuppressive therapy-National Institute of Allergy and Infectious Diseases (NIAID)-kidney transplant rejection

Standard immunosuppressive therapy (NIAID CTOT-09 regimen) is a multi-drug combination protocol used for the prevention of kidney transplant rejection. It consists of an induction phase using rabbit antithymocyte globulin (rATG), a polyclonal antibody that causes rapid T-cell depletion, followed by a triple-drug maintenance phase. The maintenance components include tacrolimus, a calcineurin inhibitor that blocks T-cell activation; mycophenolate mofetil (MMF), an antimetabolite that inhibits lymphocyte proliferation by targeting inosine monophosphate dehydrogenase (IMPDH); and prednisone, a corticosteroid with broad immunosuppressive activity. This specific regimen served as the standard-of-care control in the NIAID-sponsored CTOT-09 Phase 2 trial, which investigated the feasibility of tacrolimus withdrawal in low-risk recipients. The trial was terminated early because patients in the withdrawal arm experienced significantly higher rates of acute rejection and development of donor-specific antibodies compared to those remaining on this standard therapy.

Brand names

ThymoglobulinPrografCellCept

Other names

Standard Immunosuppressive TherapyrATG + Tacrolimus + MMF + Prednisone