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news.US-based Alexion Pharmaceuticals has began dosing in a single, multinational, placebo-controlled clinical trial to evaluate the efficacy and safety of eculizumab (Soliris) to prevent delayed graft function (DGF) after kidney transplantation in adult patients who are at increased risk of DGF.
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About 25% and possibly up to 50% of deceased-donor kidney transplant cases are affected by DGF, an early and serious complication of organ transplantation.
DGF is characterized by the failure of a transplanted organ to function normally immediately after transplantation.
In order to survive, patients experiencing DGF after a kidney transplant need to undergo dialysis and currently, there are no approved treatments to prevent DGF after kidney transplantation.
In most cases DGF results from ischemia/reperfusion injury (IRI), which is due to multiple processes that occur following the restoration of blood flow to an area that had previously experienced deficient blood flow.
Uncontrolled complement activation following IRI is believed to play a major role in the development of DGF.
Alexion executive vice-president and global head of R&D Martin Mackay said delayed graft function is a serious and significant complication to successful kidney transplantation, which can be life-threatening due to the risk of losing the transplanted organ.
"Since complement activation plays a critical role in the development of DGF, a terminal complement inhibitor like eculizumab may have the potential to prevent this devastating complication," Mackay said.
"In addition, as donor organs are in short supply, reducing the risk of DGF may allow more deceased-donor organs to be successfully transplanted, which could potentially shorten the waiting time to receive a transplant."
Soliris is approved in about 50 countries for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) and in nearly 40 countries for the treatment of atypical hemolytic uremic syndrome (aHUS).
PNH and aHUS are two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation.
Image: Currently, Soliris is approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome (aHUS). Photo: courtesy of Alexion.