A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of SC0062 Capsule in Patients with IgA Nephropathy and Proteinuria (SUCCESS-1)
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.
• 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:
‣ 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.
⁃ 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).
⁃ The pathological examination confirmed IgA nephropathy. Two 24-hour urine samples were collected during the screening period, after 12 weeks of the stable use of the background treatment. Both of the results conducted by the central laboratory were met: 24-hour urine protein to creatinine ratio (UPCR) ≥ 0.75 g/g or 24-hour urinary protein excretion rate (UPER) ≥ 1.0 g.
• Laboratory tests shall meet the following criteria:
‣ Serum albumin ≥ 30 g/L;
⁃ Hemoglobin ≥ 90 g/L ; Platelet count ≥80×109/L;
⁃ Brain natriuretic peptide (BNP) ≤ 200 pg/mL or N-terminal pro B-type natriuretic peptide (NT-proBNP) ≤ 600 pg/mL;
⁃ Blood potassium ≤ 5.5 mmol/L;
⁃ Systolic blood pressure (SBP) ≤ 160 mmHg;
⁃ Hemoglobin A1c ≤ 8%;
⁃ Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2×ULN; Total bilirubin ≤ 1.5×ULN;
• During the entire study period from the signing of the informed consent to 3 months after the final administration, fertile females and males who have not received vasectomy should take effective contraceptive measures \[Effective contraceptive measures include: Vasectomy, intrauterine device (IUD), hormones (oral, patch, ring, injection, implant) and barrier methods (diaphragm, cervical cap, sponge, condom).