Long-term safety and tolerability of HRS-5965 in 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 is a phase 2 interventional trial evaluating long-term safety and tolerability of HRS-5965 capsules in patients with primary IgA nephropathy. The study also explores efficacy signals by measuring 24-hour urinary protein and changes in estimated glomerular filtration rate over time. Eligible participants include those who completed a prior HRS-5965 trial or discontinued during maintenance after starting rescue therapy. Participants must understand the procedures and provide informed consent. The trial is conducted at a single site in Beijing, sponsored by Chengdu Suncadia Medicine Co., Ltd., with no listed collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with primary IgA nephropathy who completed treatment in Study HRS-5965-305, or who prematurely discontinued study drug during the maintenance phase following initiation of rescue therapy;
2. Understand the research procedures and methods, voluntarily participate in this trial and sign the informed consent form in person.

Exclusion Criteria:

1. Hypersensitivity to the study drug or its components；
2. History of immunodeficiency disorders；
3. History of invasive encapsulated bacterial infection；
4. History of malignant neoplasm；
5. The estimated glomerular filtration rate (eGFR) is less than 20 mL/min/1.73m2；

Where it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Yanfang Zou
• Email: yanfang.zou@hengrui.com
• Phone: +0518-82342973

Similar studies

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

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• HRS-5965 capsule for primary IgA nephropathy

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

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• JADE101 in IgA Nephropathy: a Phase 2 test in adults

  This Phase 2 open-label study tests JADE101 in adults with IgA nephropathy to see how safe it is and how well it works when added to standard care.

  Recruiting at 22 sites Phase 2 Jade Biosciences, Inc. · Chula Vista, California and 21 other locations · NCT07541287

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.