Composite Efficacy Endpoints in Kidney Transplant

The primary efficacy end point was a composite of BPAR, de novo donor-specific antibody formation, and graft failure at 12 months after kidney transplantation. BPAR was determined by pathological evidence interpreted by the Banff criteria [20 (link)–23 (link)]. Delayed graft function was defined as the need for dialysis during the first week after transplantation, excluding a single session for the treatment of hyperkalemia. Kidney graft failure was defined as the need for a transplant nephrectomy, retransplant, or recommencement of dialysis. The secondary efficacy end point was renal function determined by eGFR (CKD-EPI) at one and six months post-transplant and one and two years post-transplant. The safety end points included infection, leukopenia, thrombocytopenia, and malignancy. Leukopenia was defined as a white cell count of less than 2500 per cubic millimeter. Thrombocytopenia was defined as a platelet count of less than 80,000 per cubic millimeter.