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Recruiting 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;

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07582133). StuddyBuddy aggregates publicly available trial information.