A Study of SC0062 Capsule for the Treatment of IgA Nephropathy with Proteinuria
Trial Parameters
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of SC0062 capsule compared to placebo in patients with IgA nephropathy in the presence of proteinuria. The participants must have a high risk of disease progression, despite of stable use of the maximum tolerated labelled or optimized dose of RAASi and/or SGLT2i for at least 12 weeks prior to randomization.
Eligibility Criteria
Inclusion Criteria: * Voluntarily sign informed consent and fully understand and comply with trial procedures; * Age ≥18 years old, gender unlimited; * IgA nephropathy patients with proteinuria must meet all of the following conditions: 1. According to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI, 2009) creatinine equation, after 12 weeks of the stable use of the background therapy, the mean of two estimated glomerular filtration rates (eGFR) calculated from central laboratory results was ≥ 30 and \< 90 mL/min/1.73m2. 2. Received the maximum labeled or tolerated dose of RAASi (ACEI or ARB) for at least 12 weeks before randomization; If subjects were treated with SGLT2i, MRA, or GLP-1RA prior to randomization, the stable use was also required for at least 12 weeks (maximum tolerated and optimal dose determined by the investigator; Subjects who are intolerant to RAASi may also be enrolled). 3. The pathological examination confirmed IgA nephropathy. Two 24-hour urine sam