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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
288
NEFECON 8mg once daily by mouth for 15 months
Placebo oral capsule once daily by mouth for 15 months
Nanfang hospital, Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGTime 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
Time frame: 15 months
eGFR slope
eGFR slope from baseline to Month 15
Time frame: 15 months
The proportion of patients with UPCR ≥0.5 g/g
The proportion of patients with sustained UPCR ≥0.5 g/g
Time frame: 15 months
The proportion of patients with UPCR ≥1 g/g
The proportion of patients with sustained UPCR ≥1 g/g
Time frame: 15 months
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
Time frame: 3, 6, 9, 12, and 15 Months
Major adverse kidney events
The proportion of patients with the first occurrence of major adverse kidney events within 15 months, defined as the occurrence of any one of the following: eGFR ≤15 ml/min/1.73m², maintenance dialysis, kidney transplantation, ≥30% decrease in eGFR, or kidney-related death
Time frame: 15 months
All-cause mortality
All-cause mortality
Time frame: 15 months
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