Safety and tolerability of darbepoetin alfa single intravenous administration in maintenance hemodialysis patients
SUN Lin-lin, RONG Shu, YE Chao-yang, SUN Li-jun, CAI Hou-an, MA Xiao-hong, CHEN Jing, ZHAO Xue-zhi, XU Cheng-gang, SUN Jian-jun, MEI Chang-lin
Published 2009-12-15
Cite as Chin J Neahrol, 2009,25(11): 832-836. DOI: 10.3760/cma.j.issn.1001-7097.2009.11.004
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.
Key words:
Hemodialysis; Safety; Drug tolerance; Darbepoetin alfa
Contributor Information
SUN Lin-lin
Division of Nephrology,Changzheng Hospital,the Second Military Medical University,Shanghai 200003,China
RONG Shu
Division of Nephrology,Changzheng Hospital,the Second Military Medical University,Shanghai 200003,China
YE Chao-yang
Division of Nephrology,Changzheng Hospital,the Second Military Medical University,Shanghai 200003,China
SUN Li-jun
Division of Nephrology,Changzheng Hospital,the Second Military Medical University,Shanghai 200003,China
CAI Hou-an
Division of Nephrology,Changzheng Hospital,the Second Military Medical University,Shanghai 200003,China
MA Xiao-hong
Division of Nephrology,Changzheng Hospital,the Second Military Medical University,Shanghai 200003,China
CHEN Jing
Division of Nephrology,Changzheng Hospital,the Second Military Medical University,Shanghai 200003,China
ZHAO Xue-zhi
Division of Nephrology,Changzheng Hospital,the Second Military Medical University,Shanghai 200003,China
XU Cheng-gang
Division of Nephrology,Changzheng Hospital,the Second Military Medical University,Shanghai 200003,China
SUN Jian-jun
Division of Nephrology,Changzheng Hospital,the Second Military Medical University,Shanghai 200003,China
MEI Chang-lin
Division of Nephrology,Changzheng Hospital,the Second Military Medical University,Shanghai 200003,China