Recruiting NCT07289763
Phase II Randomized, Open-label, Multicenter Clinical Study Evaluating the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of SHR-2173 Injection in Patients With Primary Membranous Nephropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-2173 injection, SHR-2173 injection, SHR-2173 injection.
- Who it may be relevant to
- Registry conditions: Primary Membranous Nephropathy. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
To investigate the safety, efficacy, pharmacokinetics, and pharmacodynamics of SHR-2173 injection in patients with primary membranous nephropathy
Interventions
- Drug SHR-2173 injection
SHR-2173 injection, with a total of 8 administrations - Drug SHR-2173 injection
SHR-2173 injection, with a total of 16 administrations - Drug SHR-2173 injection
SHR-2173 injection , with a total of 32 administrations
Primary outcome measures
- Adverse events [Time frame: Week0, 2, 4, 8, 12,16, 20, 24, 28, 32, 36, 40, 48 52]
- 12-lead ECG [Time frame: Week4, 8, 12, 24, 28, 36, 52]
Secondary outcome measures (3)
- The proportion of subjects who achieved overall response (including complete response (CR) and partial response (PR)). [Time frame: Week 12, 24, 36, 52]
- The proportion of subjects who achieved CR [Time frame: Week 12, 24, 36, 52]
- The proportion of subjects who achieved PR [Time frame: Week 12, 24, 36, 52]
Eligibility criteria
Inclusion criteria
- Age 18-75 years, regardless of gender;
- Weight ≥40.0 kg at screening;
- Diagnosed as primary membranous nephropathy through kidney biopsy.
Exclusion criteria
- Secondary membranous nephropathy.
- Subjects developed rapidly progressive glomerulonephritis or required kidney transplantation.
- Subjects who have undergone kidney dialysis in the previous 12 months or are expected to require dialysis during the study period.
- Subjects who have a malignant tumor or a history of malignant tumor
- Subjects who have undergone major surgery within the previous 3 months, or plan to undergo major surgery during the study period.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- General hospital of eastern theater command — Nanjing
Identifiers
NCT: NCT07289763 · SHR-2173-201