IgA nephropathy (IgAN), also known as Berger’s disease, is a rare kidney disorder characterized by the deposition of immunoglobulin A (IgA) in the glomeruli, which can lead to glomerulonephritis and progressive kidney damage. The condition presents clinical management challenges due to its variable progression, ranging from benign to rapid decline in kidney function. Recent advancements in treatment options are shedding light on the potential for significant clinical outcomes, particularly evidenced through the ongoing APPLAUSE-IgAN trial investigating the efficacy of iptacopan (brand name Fabhalta), a drug representing a novel intervention in the management of this disorder.
A pivotal analysis from the phase III APPLAUSE-IgAN trial, presented at the American Society of Nephrology Kidney Week meeting, indicated a clinically relevant reduction in proteinuria among patients administered with iptacopan. Data derived from the first cohort of 250 patients randomized to receive either iptacopan or a placebo revealed that those in the iptacopan arm demonstrated a staggering 38.3% reduction in the adjusted geometric mean of the 24-hour urinary protein-to-creatinine ratio (UPCR), a primary outcome marker. This impressive reduction, confirmed by statistical significance (P
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