Phase II Randomized, Open-label, Multicenter Clinical Stu... | NCT07289763

Studies
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

NCT07289763

Sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Status

Recruiting

Last Update Posted

Jan 26, 2026Actual

Enrollment

75Estimated

Phase

Phase 2

Conditions

Primary Membranous Nephropathy

Interventions

SHR-2173 injection
SHR-2173 injection
SHR-2173 injection

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 31, 2025Actual

Primary Completion Date

Aug 2027Estimated

Completion Date

Sep 2027Estimated

First Submitted Date

Nov 20, 2025

First Submission Date that Met QC Criteria

Dec 4, 2025

First Posted Date

Dec 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2026

Last Update Posted Date

Jan 26, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To investigate the safety, efficacy, pharmacokinetics, and pharmacodynamics of SHR-2173 injection in patients with primary membranous nephropathy

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Treatment group A	Experimental	Drug: SHR-2173 injection
Treatment group B	Experimental	Drug: SHR-2173 injection
Treatment group C	Experimental	Drug: SHR-2173 injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SHR-2173 injection	Drug	SHR-2173 injection, with a total of 8 administrations	Treatment group A

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhe Zhang	Contact	+0518-81220121		zhe.zhang@hengrui.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
General hospital of eastern theater command	Recruiting	Nanjing	Jiangsu	210002	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.