IgA nephropathy (IgAN) is a chronic progressive kidney disease, and long-term control of proteinuria and prevention of relapse are crucial for delaying disease progression. Patients with IgAN who achieve proteinuria remission after receiving Nefecon for 9 months or longer still face the risk of proteinuria relapse after treatment discontinuation. This study is to evaluate the efficacy and safety of Nefecon 8 mg treatment for 15 months as a maintenance therapy to reduce the risk of IgAN relapse in proteinuria-remitted patients.
Diagnosed primary IgAN with biopsy verification;
Female or male participants ≥18 years of age;
Completion of ≥9 months of Nefecon 16 mg QD at the baseline visit;
Proteinuria ≥ 1g/d prior to initiation of Nefecon;
Systemic diseases that may cause mesangial immunoglobulin A deposition, including but not limited to IgA vasculitis nephritis, systemic lupus erythematosus, dermatitis herpetiformis, ankylosing spondylitis, and others;
Type 1 or type 2 diabetes mellitus;
Presence of primary or secondary glomerulopathies (e.g., membranous nephropathy, focal segmental glomerulosclerosis, C3 glomerulopathy and others);
Active infection, severe hepatic impairment (Child-Pugh Class C), congestive heart failure, and malignant tumor within the past 5 years;
Parallel
NEFECON
DrugNEFECON 8mg once daily by mouth for 15 months
Placebo
DrugPlacebo oral capsule once daily by mouth for 15 months
Time to first composite disease relapse
either a ≥100% increase in UPCR and an absolute UPCR ≥0.5 g/g, or a ≥30% decline in eGFR from randomization
eGFR slope
eGFR slope from baseline to Month 15
The proportion of patients with UPCR ≥0.5 g/g
The proportion of patients with sustained UPCR ≥0.5 g/g
The proportion of patients with UPCR ≥1 g/g
The proportion of patients with sustained UPCR ≥1 g/g
Changes in UPCR and 24-hour urinary protein
Changes in UPCR and 24-hour urinary protein from baseline to Months 3, 6, 9, 12, and 15
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