A Trial to Evaluate the Long-term Safety and Tolerability of HRS-5965 in Patients With Primary IgA Nephropathy

Recruiting now · Phase 2

Conditions studied: Primary IgA Nephropathy

In brief

This study aims to evaluate the long-term safety of HRS-5965 capsules in patients with primary IgA nephropathy, and also to assess its efficacy in reducing 24-hour urinary protein and delaying the decline in eGFR in these patients.

Key facts

Study ID

NCT07582133

Run by

Chengdu Suncadia Medicine Co., Ltd.

People needed

380

Starts

2026-07-06

Expected to finish

2029-11-01

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;
• Understand the research procedures and methods, voluntarily participate in this trial and sign the informed consent form in person.

You may not qualify if…

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

Where it is running

• Peking University First Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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