Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Status:
Not yet recruiting
Trial end date:
2025-09-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and
pharmacodynamics (PD) of KP104 in participants with IgAN and C3G. The study will start with
enrolling the IgAN cohort. Approximately 42 participants with IgAN will be enrolled in 2
stages: Stage 1 will be used to collect safety, immunogenicity, PK, and PD data to select the
optimal biologic dose (OBD) of KP104 for IgAN. Stage 2 will be used to collect safety,
immunogenicity, PK, PD, and efficacy data at the OBD dose of KP104. As soon as the OBD for
IgAN is determined, eligible participants with C3G will be enrolled and dosed at the OBD for
IgAN for a minimum of 48 weeks for weekly maintenance dosing and a minimum of 47 weeks for
biweekly maintenance dosing. Approximately 10 participants with C3G will be enrolled.