SHR-2173 for people with primary IgA nephropathy

A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-2173 Injection in Patients With Primary IgA Nephropathy

This trial will test whether SHR-2173 injections can reduce proteinuria and protect kidney function in adults with primary IgA nephropathy compared with placebo over 48 weeks.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 2 sites (Guangzhou, Guangdong and 1 other locations)
• Trial ID: NCT07354932 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled Phase II trial will enroll about 84 adults with primary IgA nephropathy who meet proteinuria and eGFR entry criteria. After a screening and run-in period, participants will receive SHR-2173 or placebo injections during a 48-week double-blind treatment period followed by a 12-week safety follow-up. The study will compare changes in proteinuria and kidney function while monitoring safety and tolerability. Background standard-of-care treatments and protocol-specified contraception measures are maintained throughout the trial.

Who should consider this trial

Good fit: Adults aged 18 or older with primary IgA nephropathy, 24-hour protein ≥1 g/day or UPCR ≥0.7 g/g, eGFR ≥30 mL/min/1.73 m2, and meeting the protocol's weight, BMI, and contraception requirements are the ideal candidates.

Not a fit: Patients with secondary causes of IgAN, a history of organ transplantation or splenectomy, recent or active malignancy, eGFR below 30 mL/min/1.73 m2, or proteinuria below the entry thresholds are unlikely to benefit from participation.

Why it matters

Potential benefit: If SHR-2173 is effective, it could lower proteinuria and slow decline in kidney function, reducing the long-term risk of kidney failure for people with IgAN.

How similar studies have performed: Some other targeted therapies for IgAN have shown promising results in early trials, but SHR-2173 itself is a newer investigational agent without large Phase III data published yet.

Eligibility criteria

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:

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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.

Where this trial is running

Guangzhou, Guangdong and 1 other locations

• The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Kunming Li

Conditions Primary IgA Nephropathy