Clinical application of FR-860 to hemodialysis: Multicenter cooperative study in Japan.

A multicenter cooperative study was designed to evaluate the efficacy and safety of FR-860 as an anticoagulant in hemodialysis. Sixty-five stable maintenance hemodialysis patients were enrolled into the study from fourteen institutions in Japan. 4 cases were excluded from the efficacy analysis because of protocol deviation (a violation of the concomitant drugs). The period of the study was fixed at two weeks. Dosage requirements were 15.0-20.0 anti-Xa units/kg as a bolus and 7.5-10.0 anti-Xa units/kg/hr for continuous hourly administration. Total dosage of FR-860 (F) was 2, 505±127 anti-Xa units compared to that of a conventional heparin (CH) dose of 6, 124 ±190 units. No difference in the residual blood in the extracorporeal circuit was observed between the F and CH groups. The hemostatic time at the puncture site after the completion of dialysis was significantly shortened in the F group (7.9±0.7 min) in comparison with the CH group (11.4±1.1 min; p<0.01). The plasma anti-Xa levels were 0.24±0.03 and 0.36±0.04 units/ml 1 hr after the initiation and at the completion of dialysis, respectively. ACT, measured by the Hemochron method, was not prolonged during dialysis. APTT varied from 34.3±1.2 before dialysis to 41.0±1.9 (p<0.01) 1 hr after the start of dialysis and 39.9±1.6 sec (p<0.01) at the end of dialysis. Plasma AT III activity increased from 96.8±2.5 before dialysis to 113.0±3.2% (p<0.01) at the end of dialysis. No significant changes were observed in either ADP-or collagen-induced platelet aggregation during dialysis. Dialysis efficiency in the F group was similar to that in the CH group. Slight itching developed in one of the 65 cases. No abnormal laboratory data were observed during the study.In conclusion, FR-860 was demonstrated to be a convenient alternative to conventional heparin as an anticoagulant in hemodialysis treatment.