[Translation] A single-arm, multicenter Phase II/III study to evaluate the efficacy, safety, pharmacokinetic characteristics, and immunogenicity of KJ103 in desensitization therapy in highly sensitized renal transplant patients
II期:
主要目的:
评估KJ103在等待肾移植的高度致敏患者脱敏治疗的初步疗效。
次要目的:
评估KJ103给药后安全性、PRA和DSA水平、PK特征、PD特征、免疫原性。
III期:
主要目的:
评估KJ103在等待肾移植的高度致敏患者脱敏治疗的疗效。
次要目的:
评估KJ103给药后安全性、DSA水平和PRA水平、PK特征、PD特征、免疫原性、肾功。
[Translation] Phase II:
Main purpose:
To evaluate the preliminary efficacy of KJ103 in desensitization therapy for highly sensitized patients waiting for renal transplantation.
Secondary purpose:
To evaluate the safety, PRA and DSA levels, PK characteristics, PD characteristics, and immunogenicity of KJ103 after administration.
Phase III:
Main purpose:
To evaluate the efficacy of KJ103 in desensitization therapy for highly sensitized patients waiting for renal transplantation.
Secondary purpose:
To evaluate the safety, DSA and PRA levels, PK characteristics, PD characteristics, immunogenicity, and renal function of KJ103 after administration.