Study on the pharmacokinetics and pharmacodynamics of rhEPO-Fc in patients with renal anemia
ZHANG Wen-mei
TIAN Fang
QU Heng-yan
XU Hui
LIU Jing
YANG Chun
LI Xiao-wen
GUO Xin-lei
WANG Jia-ning
Abstract：Objective:To explore the pharmacokinetic and pharmacodynamic characteristics of recombinant human erythropoietin-Fc fusion protein(rhEPO-Fc)in patients with renal anemia,and preliminarily observe its efficacy and safety.Methods:Stable chronic renal failure subjects who had received hemodialysis for more than 3 months were enrolled and administered with initial doses of rhEPO-Fc at 12,18 and 24 pg·kg-1 via intravenous injection once weekly for 6 consecutive weeks.Pharmacokinetics,pharmacodynamics,efficacy,and safety were evaluated.Results:A total of 35 subjects were enrolled,and 31 completed the clinical trial.After intravenous injection of 12,18 and 24 pg·kg-1 rhEPO-Fc,the mean half-lives were 17.27,13.29 and 19.63 h,respectively.Cmax and AUC showed a linear relationship with the dose.Steady-state plasma concentration was achieved after 3 weeks of once-weekly intravenous injection.In each dose group,the mean reticulocyte count increased after the first intravenous injection of rhEPO-Fc and peaked after 7 d.After 6 weeks of administration,red blood cell count and hemoglobin levels significantly increased.Adverse reactions occurred in 10 subjects(33 cases),with an incidence of 28.6％.No severe adverse reactions or events leading to patient withdrawal were observed.Conclusion:rhEPO-Fc has a long half-life in patients with renal anemia,shows no accumulation after multiple administrations,can improve the anemia status of these patients,and has good tolerability and safety.
Keywords：hemodialysisrenal anemiaerythropoietinpharmacokineticspharmacodynamics
Publication Date：2025-11-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 2423-2428 )