SHR-2173 injections for adults with primary membranous nephropathy
Official title: 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
Run by Guangdong Hengrui Pharmaceutical Co., Ltd · NCT07289763 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | Guangdong Hengrui Pharmaceutical Co., Ltd Industry-sponsored |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | December 31, 2025 |
| Main results expected | August 2027 |
| Study ends | September 2027 |
| Registry record updated | January 26, 2026 |
| Trial ID | NCT07289763 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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General hospital of eastern theater command
Nanjing, Jiangsu, China Recruiting
Study contacts
- Study coordinator: Zhe Zhang
- Email: zhe.zhang@hengrui.com
- Phone: +0518-81220121
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Surovatamig for adults with anti‑PLA2R primary membranous nephropathy
This study will test whether subcutaneous surovatamig is safe and can reduce heavy proteinuria in adults with anti‑PLA2R–positive primary membranous nephropathy.
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Povetacicept for people with primary membranous nephropathy
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ALXN1920 for adults with primary membranous nephropathy
This trial will test whether ALXN1920 reduces urine protein in adults with primary membranous nephropathy who are at high risk of progression compared with placebo.
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Budoprutug for primary membranous nephropathy (Phase 2)
This trial will test whether budoprutug, an anti-CD19 antibody given by IV, is safe and tolerated and may reduce proteinuria in adults with PLA2R-positive primary membranous nephropathy who still have high protein in their urine despite RAAS blockers.
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Evaluating YK012 for treating primary membranous nephropathy
This study is testing a new treatment called YK012 to see if it can help people with primary membranous nephropathy feel better and how safe it is to use.
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Felzartamab infusions for adults with primary membranous nephropathy
This study tests whether felzartamab infusions help adults with primary membranous nephropathy reach complete remission of proteinuria compared with tacrolimus.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.