A total of 28 patients undergoing chronic haemodialysis were enrolled in an open-label multi-centre trial. Various doses were tested across a maximum of three dialysis sessions. All patients received TGN 255 and intra-patient results were compared to a baseline haemodialysis session on heparin.
The trial concluded that a continuous infusion of TGN 255 was well tolerated at all dose levels tested. Increased doses of TGN 255 were associated with decreased extracorporeal circuit clotting. In all cases clotting was not clinically significant and no session was either interrupted or prematurely terminated.
The results were presented at the European Renal Association and European Dialysis and Transplantation Association Congress in Glasgow, Scotland.
“These results confirm our initial confidence in TGN 255 as a potentially safe and effective anticoagulant for the prevention of clotting during haemodialysis sessions,” said Dr Sophie Combe, VP Clinical Development at Trigen.
The company further said that plans for the further development of TGN 255 for the prevention of clotting in haemodialysis patients intolerant to the most widely used anticoagulant, heparin, are well advanced.
Approximately 2% of haemodialysis patients suffer heparin- induced thrombocytopenia (HIT), a potentially dangerous immunological reaction which overrides the normal anticoagulant effect of heparin and instead increases the overall risk of thrombosis.
An even greater number of patients have antibodies against heparin and may be at risk of developing HIT. Patients with HIT should no longer receive heparin and TGN 255 may provide a safe and effective alternative anticoagulation strategy in this patient group.