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

NCT07354932 | Recruiting Phase 2

• 1 other identifier: SHR-2173-205
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Primary IgA Nephropathy

Outcome Measures

Primary Outcomes (1)

• Change from baseline in 24-hour Urine Protein-to-Creatinine Ratio (UPCR) at Week 24.

  Week 24.

Secondary Outcomes (12)

• Change from baseline in 24-hour UPCR ;

  up to Week 48

• Change from baseline in 24-hour Urinary Albumin-to-Creatinine Ratio (UACR) ;

  up to Week 48

• Proportion of participants with 24-hour urinary protein quantification <0.5 g/d and <0.3 g/d ;

  up to Week 48

• Proportion of participants with >30% and >50% reduction from baseline in 24-hour UPCR ;

  up to Week 48

• Change from baseline in 24-hour urinary protein quantification ;

  up to Week 48

Study Arms (4)

Treatment group A: SHR-2173 injection

EXPERIMENTAL

Drug: SHR-2173 injection

Treatment group B: SHR-2173 injection

EXPERIMENTAL

Drug: SHR-2173 injection

Treatment group C: SHR-2173 injection

EXPERIMENTAL

Drug: SHR-2173 injection

Placebo Group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SHR-2173 injection DRUG

SHR-2173 injection；High dose

Treatment group A: SHR-2173 injection

Placebo DRUG

Placebo

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants aged 18 or older
• Body weight ≥35 kg, BMI\<37.5 kg/m2
• At screening, 24-hour urinary protein quantification ≥1 g/ day, or 24-hour UPCR≥0.7 g/g
• eGFR≥30 mL/ minute /1.73 m2 at screening
• 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

You may not qualify if:

• 、Presence of any of the following medical histories or comorbidities:
• 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;
• A history of organ transplantation;
• A history of splenectomy;
• 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);
• 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
• 、Use of any of the following drugs/treatments or participation in a clinical study:
• 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);
• Receivied immunosuppressive therapy within 12 weeks before randomization;
• Received any investigational drug within 4 weeks before randomization or within the 5 half-lives of the trial drug, whichever was longer;
• Received a live / attenuated live vaccine administered within 4 weeks before randomization
• 、History and examination related to infection:
• 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;
• Tuberculosis (TB) or occult TB infection (one of the following conditions) :
• Presence of active TB or clinical symptoms of active TB at screening;

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (2)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Kunming Li

CONTACT

0518-82342973; kunming.li@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 21, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-01

Locations

CN (2)