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

NCT ID: NCT07289763

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Membranous Nephropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment group A

Group Type EXPERIMENTAL

SHR-2173 injection

Intervention Type DRUG

SHR-2173 injection, with a total of 8 administrations

Treatment group B

Group Type EXPERIMENTAL

SHR-2173 injection

Intervention Type DRUG

SHR-2173 injection, with a total of 16 administrations

Treatment group C

Group Type EXPERIMENTAL

SHR-2173 injection

Intervention Type DRUG

SHR-2173 injection , with a total of 32 administrations

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SHR-2173 injection

SHR-2173 injection, with a total of 8 administrations

Intervention Type DRUG

SHR-2173 injection

SHR-2173 injection, with a total of 16 administrations

Intervention Type DRUG

SHR-2173 injection

SHR-2173 injection , with a total of 32 administrations

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Guangdong Hengrui Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

General hospital of eastern theater command

Nanjing, Jiangsu, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zhe Zhang

Role: CONTACT

Phone: +0518-81220121

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SHR-2173-201

Identifier Type: -

Identifier Source: org_study_id