About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Hypersensitivity to the study drug or its components;
History of immunodeficiency disorders;
History of invasive encapsulated bacterial infection;
History of malignant neoplasm;
Trial design
Single group
Treatments tested in this trial
HRS-5965 Capsules
DrugHRS-5965 Capsules
Treatment groups
Trial outcomes
Primary outcomes
The incidence and severity of adverse events (AEs) throughout the study;
Secondary outcomes
Ratio of 24-hour urine protein excretion (24-UPE) to baseline;
The change from baseline in estimated glomerular filtration rate (eGFR);
The change from baseline in serum creatinine (Scr);
The proportion of participants with 24-UPE < 0.5 g/d;
Sponsors and contacts
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