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

January 22, 2026 updated by: Guangdong Hengrui Pharmaceutical Co., Ltd
To investigate the safety, efficacy, pharmacokinetics, and pharmacodynamics of SHR-2173 injection in patients with primary membranous nephropathy

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Recruiting
        • General Hospital of Eastern Theater Command
        • Principal Investigator:
          • Liangjing Lv
        • Principal Investigator:
          • Zhihong Liu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group A
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
Experimental: Treatment group B
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
Experimental: Treatment group C
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: Week0, 2, 4, 8, 12,16, 20, 24, 28, 32, 36, 40, 48 52
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
Week4, 8, 12, 24, 28, 36, 52

Secondary Outcome Measures

Outcome Measure
Time Frame
The proportion of subjects who achieved overall response (including complete response (CR) and partial response (PR)).
Time Frame: Week 12, 24, 36, 52
Week 12, 24, 36, 52
The proportion of subjects who achieved CR
Time Frame: Week 12, 24, 36, 52
Week 12, 24, 36, 52
The proportion of subjects who achieved PR
Time Frame: Week 12, 24, 36, 52
Week 12, 24, 36, 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

December 4, 2025

First Posted (Actual)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • SHR-2173-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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