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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
380
HRS-5965 Capsules
Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe incidence and severity of adverse events (AEs) throughout the study;
Time frame: 2 years
Ratio of 24-hour urine protein excretion (24-UPE) to baseline;
Time frame: 2 years
The change from baseline in estimated glomerular filtration rate (eGFR);
Time frame: 2 years
The change from baseline in serum creatinine (Scr);
Time frame: 2 years
The proportion of participants with 24-UPE < 0.5 g/d;
Time frame: 2 years
The proportion of participants with 24-UPE < 0.3 g/d;
Time frame: 2 years
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