NCT07289763

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
16mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Dec 2025Sep 2027

First Submitted

Initial submission to the registry

November 20, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

December 31, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

January 26, 2026

Status Verified

November 1, 2025

Enrollment Period

1.6 years

First QC Date

November 20, 2025

Last Update Submit

January 22, 2026

Conditions

Primary Membranous Nephropathy

Outcome Measures

Primary Outcomes (2)

  • 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 (3)

  • 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

  • The proportion of subjects who achieved PR

    Week 12, 24, 36, 52

Study Arms (3)

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

SHR-2173 injectionDRUG

SHR-2173 injection, with a total of 8 administrations

Treatment group A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75 years, regardless of gender;
  • Weight ≥40.0 kg at screening;
  • Diagnosed as primary membranous nephropathy through kidney biopsy.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General hospital of eastern theater command

Nanjing, Jiangsu, 210002, China

RECRUITING

Central Study Contacts

Zhe Zhang

CONTACT

+0518-81220121zhe.zhang@hengrui.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 17, 2025

Study Start

December 31, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

January 26, 2026

Record last verified: 2025-11

Locations

CN(1)