Efficacy and Safety of Nefecon on Prevention of Relapse of IgA Nephropathy: a Randomized, Double-blinded, Placebo-Controlled Trial
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;
• Proteinuria\<0.5 g/day (or UPCR \<0.5 g/g) at screening and randomization visit;
• eGFR ≥30 ml/min/1.73m² at screening;
• On stable treatment with supportive treatment (including RAASi, SGLT2i, ERA) for at least 1 month prior to the baseline visit;