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Clinical Trials in China / NCT07354932
Recruiting Phase 2

A Study of SHR-2173 in Participants With Primary IgA Nephropathy

NCT07354932 · tracked via the Priya Life Science China tracker
Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Phase
Phase 2
Started
2026-03-09
Last updated
2026-05-13

Condition(s) studied

Primary IgA Nephropathy

Investigational drug(s) / intervention(s)

SHR-2173 injectionSHR-2173 injectionSHR-2173 injectionPlacebo

SHR-2173 injection: SHR-2173 injection;High dose

SHR-2173 injection: SHR-2173 injection;Medium dose

SHR-2173 injection: SHR-2173 injection;Low dose

Placebo: Placebo

Study summary

This study is a randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of SHR-2173 in patients with Primary IgA Nephropathy(IgAN). The study consists of a screening period, a run-in period, a 48-week double-blind treatment period, and a 12-week follow-up period. Approximately 84 IgAN patients will be included.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Male and female participants aged 18 or older 2. Body weight ≥35 kg, BMI\<37.5 kg/m2 3. At screening, 24-hour urinary protein quantification ≥1 g/ day, or 24-hour UPCR≥0.7 g/g 4. eGFR≥30 mL/ minute /1.73 m2 at screening 5. Female subjects with fertility or male participants whose partners are women of childbearing age must avoid donating sperm/eggs from the date of signing the ICF until 12 weeks after the last study medication, and agree to take contraceptive measures as specified in the protocol Exclusion Criteria: \- 1、Presence of any of the following medical histories or comorbidities: 1. Renal pathology consistent with IgAN, but secondary factors could not be excluded by investigator evaluation, including but not limited to: secondary to systemic diseases, infections, autoimmune diseases or tumors; 2. A history of organ transplantation; 3. A history of splenectomy; 4. Presence or history of malignancy within 5 years before screening (note: skin squamous cell carcinoma, basal cell carcinoma or cervical carcinoma in situ with complete resection and no evidence of recurrence are excluded); 5. A history of anaphylaxis such as generalized urticaria, angioedema, or anaphylaxis, or a known history of allergy to the study drug or any component of the study drug 2、Use of any of the following drugs/treatments or participation in a clinical study: 1. Received systemic glucocorticoid therapy (including gut-targeted budesonide, etc.) within 12 weeks before randomization (Note: except those not used within 4 weeks before randomization and received prednisone ≤0.5mg/kg or equivalent glucocorticoid for non-IgAN disease within 52 weeks before randomization, with no more than 3 courses (each course ≤2 weeks); 2. Receivied immunosuppressive therapy within 12 weeks before randomization; 3. Received any investigational drug within 4 weeks before randomization or within the 5 half-lives of the trial drug, whichever was longer; 4. Received a live / attenuated live vaccine administered within 4 weeks before randomization 3、History and examination related to infection: 1. A history of infection (viral, bacterial, fungal, parasitic infection) within 3 months prior to screening, resulting in hospitalization and/or parenteral systemic antimicrobial therapy; Or a history of infection requiring systemic antimicrobial therapy within 14 days before randomization; 2. Tuberculosis (TB) or occult TB infection (one of the following conditions) : 1. Presence of active TB or clinical symptoms of active TB at screening; 2. Signs of active TB on imaging examination within 3 months before screening 4、 General situation: 1\) Pregnant or lactating women; 2) Investigators determine that there are circumstances that affect the safety and efficacy evaluation of the investigational drug, or other circumstances not appropriate for participation in this study.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
The First Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong Recruiting
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality Recruiting

More Guangdong Hengrui Pharmaceutical Co., Ltd trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07354932 on ClinicalTrials.gov ↗ ← All trials in China