SHR-2173 injections for adults with primary membranous nephropathy

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

This Phase II test will try SHR-2173 injections in adults (18–75) with biopsy-proven primary membranous nephropathy to see if they are safe, reduce disease activity, and to measure how the drug acts in the body.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd (Industry-sponsored)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07289763 on ClinicalTrials.gov

What this trial studies

This is a randomized, open-label, multicenter Phase II trial of SHR-2173 given by injection to adults with biopsy-confirmed primary membranous nephropathy. Participants are randomized to receive SHR-2173 (likely across dose groups) and are followed for safety, clinical response (such as changes in proteinuria and kidney function), and pharmacokinetic/pharmacodynamic measurements. Key eligibility requires age 18–75, weight ≥40 kg, and primary membranous nephropathy confirmed by kidney biopsy. Major exclusions include secondary membranous nephropathy, rapidly progressive glomerulonephritis, recent or expected dialysis, active or prior malignancy, and recent major surgery.

Who should consider this trial

Good fit: Adults 18–75 years old with biopsy-proven primary membranous nephropathy who meet weight and health criteria and do not require dialysis are the intended participants.

Not a fit: Patients with secondary membranous nephropathy, rapidly progressive disease, recent dialysis or expected need for dialysis, active or prior cancer, or recent major surgery are excluded and unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, SHR-2173 could reduce proteinuria and help preserve kidney function in people with primary membranous nephropathy.

How similar studies have performed: Other immunotherapy approaches (for example, rituximab) have shown benefit in primary membranous nephropathy, but SHR-2173 appears to be a novel agent without published efficacy data yet.

Eligibility criteria

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.

Where this trial is running

Nanjing, Jiangsu

• General hospital of eastern theater command — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Zhe Zhang

Conditions Primary Membranous Nephropathy