Clinically relevant reduction in eGFR seen over two years with targeted release formulation of budesonide
By Elana Gotkine HealthDay Reporter
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.
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, 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.
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), with time-weighted average changes of −2.47 and −7.52 mL/minute/1.73 m2 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.
“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.
Several authors disclosed ties to pharmaceutical companies, including Calliditas Therapeutics, which manufactures Nefecon and funded the study.
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