Clinically relevant reduction in eGFR seen over two years with targeted release formulation of budesonide<\/p>\n<\/h3>\n
By Elana Gotkine HealthDay Reporter<\/b><\/p>\n
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MONDAY, Aug. 21, 2023 (HealthDay News) — For patients with immunoglobulin A (IgA) nephropathy, nine months of treatment with targeted-release formulation of budesonide (Nefecon) yields a greater reduction in estimated glomerular filtration rate (eGFR) than placebo, which lasts for two years, according to a study published online Aug. 14 in The Lancet<\/em>.<\/p>\n Richard Lafayette, M.D., from Stanford University in California, and colleagues conducted a phase 3, multicenter, randomized trial involving adults with primary IgA nephropathy, eGFR of 35 to 90 mL\/min\/1.73 m2<\/sup>, and persistent proteinuria despite optimized renin-angiotensin system blockade. Patients were randomly assigned to receive 16 mg\/day budesonide or matching placebo (182 per treatment group) for nine months followed by a 15-month observational follow-up period.<\/p>\n The researchers found that over two years, the time-weighted average of eGFR showed a significant treatment benefit with budesonide versus placebo (difference, 5.05 mL\/min\/1.73 m2<\/sup>), with time-weighted average changes of \u00e2\u0088\u00922.47 and \u00e2\u0088\u00927.52 mL\/minute\/1.73 m2<\/sup> reported with budesonide and placebo, respectively. During treatment with budesonide, the most commonly reported treatment-emergent adverse events were peripheral edema, hypertension, muscle spasms, acne, and headache. There were no reports of treatment-related deaths.<\/p>\n “The final NefIgArd study analysis has verified the clinical benefit of Nefecon treatment as the first approved, disease-specific treatment that is able to significantly reduce the rate of kidney function decline in patients with primary IgA nephropathy,” the authors write.<\/p>\n Several authors disclosed ties to pharmaceutical companies, including Calliditas Therapeutics, which manufactures Nefecon and funded the study.<\/p>\n <\/span>Abstract\/Full Text (subscription or payment may be required)<\/a><\/p>\n Editorial (subscription or payment may be required)<\/a><\/p>\n <\/i><\/p>\n