Soliris (eculizumab) fails Phase II/III PROTECT study toprevent delayed graft function.- Alexion Pharma

Alexion Pharmaceuticals, Inc. reported results from the PROTECT Study, a Phase II/III registration trial of Soliris (eculizumab) for the prevention of delayed graft function (DGF) after kidney transplantation in adult recipients of a deceased donor kidney. The primary endpoint of incidence of DGF with a two-dose regimen of eculizumab compared with placebo did not reach statistical significance.

DGF is an early and serious complication of organ transplantation in which the transplanted organ fails to function normally immediately following transplantation, and was defined in the study as the requirement for dialysis for any reason in the first 7 days post-transplant. The primary endpoint also included incidence of death, graft loss, and loss to follow-up, including discontinuation.