Primary Membranous Nephropathy
Conditions
Brief summary
To investigate the safety, efficacy, pharmacokinetics, and pharmacodynamics of SHR-2173 injection in patients with primary membranous nephropathy
Interventions
SHR-2173 injection, with a total of 8 administrations
Sponsors
Guangdong Hengrui Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-75 years, regardless of gender; 2. Weight ≥40.0 kg at screening; 3. Diagnosed as primary membranous nephropathy through kidney biopsy.
Exclusion criteria
1. Secondary membranous nephropathy. 2. Subjects developed rapidly progressive glomerulonephritis or required kidney transplantation. 3. Subjects who have undergone kidney dialysis in the previous 12 months or are expected to require dialysis during the study period. 4. Subjects who have a malignant tumor or a history of malignant tumor 5. Subjects who have undergone major surgery within the previous 3 months, or plan to undergo major surgery during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | Week0, 2, 4, 8, 12,16, 20, 24, 28, 32, 36, 40, 48 52 |
| 12-lead ECG | Week4, 8, 12, 24, 28, 36, 52 |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects who achieved overall response (including complete response (CR) and partial response (PR)). | Week 12, 24, 36, 52 |
| The proportion of subjects who achieved CR | Week 12, 24, 36, 52 |
| The proportion of subjects who achieved PR | Week 12, 24, 36, 52 |
Countries
China
Contacts
CONTACTZhe Zhang
Outcome results
None listed