Safety and tolerability of darbepoetin alfa single intravenous administration in maintenance hemodialysis patients / 中华肾脏病杂志

ABSTRACT

Objective To investigate the safety and tolerability of darbepoetin alfa.a long-lasting erythmpoietin,single intravenous administration in maintenance hemodialysis(MHD) patients. Methods A single center,open clinical trial was carried out.Forty-three stable MHD patients were divided into 5 groups and received darbepoetin α at dosage of 0.225,0.45,0.9,1.8,3.6 μg/kg respectively.The vital signs,symptoms,ECG and laboratory examinations were monitored and detected before and after administration. Results Of the 43 patients (male 26and female 17),the largest tolerable dosage of darbepoetin alfa was 3.6 μg/kg.During the study,the main side effect associated with darbepoetin was hypertension aggravation(7%).One patient died but that was not associated with darbepoetin alfa. Conclusion Darbepoetin alfa is sale and well tolerated.