Charlotte Robinson

DocwireNews

In an abstract presented at the International Society of Nephrology World Congress of Nephrology 2024, Vlado Perkovic and others offered prespecified interim analysis (IA) results from APPLAUSE-IgAN, a phase 3 study evaluating the efficacy and safety of iptacopan versus placebo with optimized supportive therapy in patients with immunoglobulin A nephropathy (IgAN).
Study participants were adults with biopsy-confirmed IgAN with proteinuria ≥1 g/g based on 24-hour urine protein-to-creatinine ratio (24h-UPCR) regardless of maximally tolerated renin-angiotensin system inhibitors (RASi) for ≥3 months, with or without sodium-glucose transport protein 2 inhibitors. Estimated glomerular filtration rate (eGFR) at baseline for the main population was ≥30 ml/min/1.73 m2. Researchers randomized patients 1:1 to receive iptacopan 200 mg or placebo twice daily for 24 months; subjects also remained on supportive therapy.
The prespecified IA occurred when the first 250 patients reached month (M) 9 or discontinued the study. The primary objective was to show superiority of iptacopan versus placebo in reducing proteinuria at M9 by measuring log-transformed ratio to baseline in 24h-UPCR. Researchers also assessed the effect on proteinuria from first morning void (FMV).
In the iptacopan versus placebo groups, median (IQR) 24h-UPCR was 1.8 (1.4-2.7) versus 1.9 (1.5-2.8) g/g, and mean (SD) eGFR was 62.7 (26.0) versus 65.5 (26.7) mL/min/1.73m2. All but two patients in the placebo group received maximally approved and/or tolerated RASi doses. By the data cutoff, fewer patients had discontinued iptacopan (16.0%) than placebo (28.0%) and fewer reached the composite kidney failure end point (6.4% vs 13.6%; per protocol).
Iptacopan proved superior to placebo in reducing proteinuria (24h-UPCR) from baseline at M9, with a reduction of 38.3% (95% CI, 26.0%-48.6%; one-sided P&lt;.0001) versus placebo. The reduction in UPCR-FMV from baseline at M9 with iptacopan versus placebo was 35.8% (95% CI, 22.6%-46.7%).
Results confirmed that iptacopan is superior to placebo in reducing proteinuria at M9, and it is well-tolerated with a favorable safety profile.
Source: <a href="https://doi.org/10.1016/j.ekir.2024.02.1414" target="_blank" rel="noopener">KI Reports</a>

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Iptacopan Demonstrates Potential for IgAN

WCN 2024

Interim analysis from the APPLAUSE-IgAN trial found favorable results for the use of iptacopan in immunoglobulin A nephropathy (IgAN).

Iptacopan Demonstrates Potential for IgAN 

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