Primary Membranous NephropathyPhase 2NCT07289763
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
A Phase 2 study testing SHR-2173 injection in people with Primary Membranous Nephropathy, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
To investigate the safety, efficacy, pharmacokinetics, and pharmacodynamics of SHR-2173 injection in patients with primary membranous nephropathy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Membranous Nephropathy
- What is being tested?
- SHR-2173 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2025to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years, regardless of gender;
- Weight ≥40.0 kg at screening;
- Diagnosed as primary membranous nephropathy through kidney biopsy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
General hospital of eastern theater command
Nanjing, Jiangsu, 210002
Liangjing Lv
Zhihong Liu
About this study
To investigate the safety, efficacy, pharmacokinetics, and pharmacodynamics of SHR-2173 injection in patients with primary membranous nephropathy
- Conditions
- Primary Membranous Nephropathy
- Being tested
- SHR-2173 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-2173 injectionDrug
SHR-2173 injection, with a total of 8 administrations
SHR-2173 injectionDrug
SHR-2173 injection, with a total of 16 administrations
SHR-2173 injectionDrug
SHR-2173 injection , with a total of 32 administrations
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Not described Receives: Drug: SHR-2173 injection |
| Treatment group B | Experimental | Not described Receives: Drug: SHR-2173 injection |
| Treatment group C | Experimental | Not described Receives: Drug: SHR-2173 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: Week0, 2, 4, 8, 12,16, 20, 24, 28, 32, 36, 40, 48 52
12-lead ECG
Measured: Week4, 8, 12, 24, 28, 36, 52
Secondary outcomes (3)
The proportion of subjects who achieved overall response (including complete response (CR) and partial response (PR)).
Measured: Week 12, 24, 36, 52
The proportion of subjects who achieved CR
Measured: Week 12, 24, 36, 52
The proportion of subjects who achieved PR
Measured: Week 12, 24, 36, 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start31 Dec 2025
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Membranous NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289763
- Sponsor's protocol ID
- SHR-2173-201
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07289763
- Acronym / sponsor ID
- SHR-2173-201
- Conditions
- Primary Membranous Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the safety, efficacy, pharmacokinetics, and pharmacodynamics of SHR-2173 injection in patients with primary membranous nephropathy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR-2173 injection |
| Treatment group B | Experimental | Drug: SHR-2173 injection |
| Treatment group C | Experimental | Drug: SHR-2173 injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-75 years, regardless of gender;
- Weight ≥40.0 kg at screening;
- Diagnosed as primary membranous nephropathy through kidney biopsy.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-2173 injectionSHR-2173 injection, with a total of 8 administrations | Drug | Treatment group A |
| SHR-2173 injectionSHR-2173 injection, with a total of 16 administrations | Drug | Treatment group B |
| SHR-2173 injectionSHR-2173 injection , with a total of 32 administrations | Drug | Treatment group C |
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Primary Membranous Nephropathy
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
A Study to Assess the Effect of Surovatamig in Adult Participants With Antibody-mediated Kidney Disease
Primary Membranous Nephropathy
Active, not recruitingPhase 1/2
An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases
Lupus Nephritis, Immunoglobulin A Nephropathy
RecruitingPhase 2
A Phase 2 Study of Budoprutug in Subjects With Primary Membranous Nephropathy
Primary Membranous Nephropathy
Not yet recruitingPhase 2
A Study to Evaluate the Effectiveness and Safety of Sibeprenlimab in Participants With Primary Membranous Nephropathy, Immune-mediated Focal Segmental Glomerulosclerosis, and Minimal Change Disease
Primary Membranous Nephropathy, Minimal Change Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-2173 injection in people with Primary Membranous Nephropathy, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhe Zhang (+0518-81220121, zhe.zhang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Week0, 2, 4, 8, 12,16, 20, 24, 28, 32, 36, 40, 48 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.