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NCT Number: NCT07289763

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

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

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Key information

Conditions

Primary Membranous Nephropathy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

General hospital of eastern theater command

Nanjing, Jiangsu, 210002, China

Location status: Recruiting

Location contact

Liangjing Lv

PRINCIPAL_INVESTIGATOR

Zhihong Liu

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SHR-2173 injection

Drug

SHR-2173 injection, with a total of 8 administrations

Primary outcomes

  1. Adverse events

    Time frame: Week0, 2, 4, 8, 12,16, 20, 24, 28, 32, 36, 40, 48 52

  2. 12-lead ECG

    Time frame: Week4, 8, 12, 24, 28, 36, 52

Secondary outcomes

  1. The proportion of subjects who achieved overall response (including complete response (CR) and partial response (PR)).

    Time frame: Week 12, 24, 36, 52

  2. The proportion of subjects who achieved CR

    Time frame: Week 12, 24, 36, 52

  3. The proportion of subjects who achieved PR

    Time frame: Week 12, 24, 36, 52

Study contacts

Contact information is provided by the study sponsor or research team.

Zhe Zhang

CONTACT

[email protected]

+0518-81220121

Sponsors and collaborators

Lead sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Industry

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 17, 2025
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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