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NCT07582133
A Trial to Evaluate the Long-term Safety and Tolerability of HRS-5965 in Patients With Primary IgA Nephropathy
Conditions: Primary IgA Nephropathy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 380
Sponsor: Chengdu Suncadia Medicine Co., Ltd.
Location: Peking University First Hospital Beijing Beijing Municipality
Summary
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.
Eligibility Criteria
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;
Source: ClinicalTrials.gov (NCT07582133). StuddyBuddy aggregates publicly available trial information.