[Translation] Efficacy, safety, pharmacokinetics and pharmacodynamics of polyethylene glycol recombinant human erythropoietin injection (CHO cells) for maintenance therapy in patients with renal anemia on regular dialysis Ⅱ Phase clinical study
主要研究目的:
探索规律透析肾性贫血患者转换为聚乙二醇重组人促红素注射液(CHO细胞)维持治疗的最佳剂量和给药方案。
次要研究目的:
(1) 评价聚乙二醇重组人促红素注射液(CHO细胞)在规律透析肾性贫血患者中长期用药的有效性和安全性;
(2) 评价聚乙二醇重组人促红素注射液(CHO细胞)在规律透析肾性贫血患者中的药代动力学、药效学及免疫原性特征。
[Translation] Main research purposes:
To explore the optimal dose and dosing schedule for switching to polyethylene glycol recombinant human erythropoietin injection (CHO cells) maintenance therapy for patients with renal anemia on regular dialysis.
Secondary research purposes:
(1) To evaluate the long-term efficacy and safety of polyethylene glycol recombinant human erythropoietin injection (CHO cells) in regular dialysis patients with renal anemia;
(2) To evaluate the pharmacokinetics, pharmacodynamics and immunogenicity of polyethylene glycol recombinant human erythropoietin injection (CHO cells) in regular dialysis patients with renal anemia.