SHR-2173 for people with primary IgA nephropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: kunming.li@hengrui.com
• Phone: 0518-82342973

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-term safety and tolerability of HRS-5965 in primary IgA nephropathy

  This study tests whether HRS-5965 capsules are safe to use over the long term and whether they can reduce 24-hour urinary protein and slow eGFR decline in adults with primary IgA nephropathy who previously completed or stopped during maintenance.

  Recruiting Phase 2 Chengdu Suncadia Medicine Co., Ltd. · Beijing, Beijing Municipality · NCT07582133

• YKST02 for adults with primary IgA nephropathy.

  This trial will test whether intravenous YKST02 is safe and can reduce urine protein in adults with primary IgA nephropathy who have persistent proteinuria despite standard treatment.

  Recruiting Early Phase 1 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07498673

• Tonsil removal plus immunosuppression for high-risk IgA nephropathy in Caucasian adults

  This trial will see if removing the tonsils combined with immunosuppressive medicine helps Caucasian adults with high-risk IgA nephropathy preserve kidney function and reduce proteinuria.

  Recruiting at 2 sites St. Petersburg State Pavlov Medical University · Saint Petersburg and 1 other locations · NCT07074951

• HRS-5965 capsule for primary IgA nephropathy

  This Phase 3 trial will test whether HRS-5965 capsules reduce proteinuria and are safe for people with biopsy-confirmed primary IgA nephropathy who have persistent proteinuria and eGFR ≥30.

  Recruiting Phase 3 Chengdu Suncadia Medicine Co., Ltd. · Beijing, Beijing Municipality · NCT07014826

• Long-term safety evaluation of iptacopan for patients with primary IgA nephropathy

  This study is testing the long-term safety of a drug called iptacopan for people with primary IgA nephropathy who have already participated in earlier trials.

  Recruiting Phase 3 Novartis · Glendale, Arizona and 160 other locations · NCT04557462

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.