[Translation] Study on the efficacy, safety and pharmacokinetics of polyethylene glycol recombinant human erythropoietin injection in different dosage regimens in patients with chronic renal failure undergoing maintenance hemodialysis
主要目的: 评价试验药(RD01)在贫血纠正后不同给药剂量、频率维持治疗的有效性和安全性。 次要目的: (1)评估RD01在不同给药剂量、频率、途径的PK/PD特征及皮下注射给药的生物利用度; (2)探索使用RD01进行贫血纠正或维持治疗(替代常规促红素)时的最佳起始剂量和给药频率。
[Translation] Primary objective: To evaluate the efficacy and safety of the investigational drug (RD01) at different doses and frequencies for maintenance therapy after anemia correction. Secondary objectives: (1) To evaluate the PK/PD characteristics of RD01 at different doses, frequencies, and routes of administration and the bioavailability of subcutaneous injection; (2) To explore the optimal starting dose and dosing frequency of RD01 for anemia correction or maintenance therapy (replacing conventional erythropoietin).