Nefecon therapy arrests estimated glomerular filtration rate decline and proteinuria in IgA Nephropathy

Throughout the 2-year experiment, patients, investigators, and site personnel were kept in the dark about the therapy. Throughout the experiment, optimal supportive care was also provided. The primary effectiveness outcome was a 2-year time-weighted average of eGFR. The entire analytic set was subjected to efficacy and safety evaluations.

The key findings of this study were:

Between September 5, 2018, and January 20, 2021, participants were enrolled for the NefIgArd experiment, with 364 patients (182 per therapy group) randomly allocated in the whole analysis set.

240 (66%) of the patients were men, 124 (34% were women), and 275 (76%) were White.

Over a 2-year period, the time-weighted average of eGFR indicated a statistically significant treatment advantage with Nefecon over placebo, with a time-weighted average change of -247 mL/min per 173 m2 recorded with Nefecon and -752 mL/min per 173 m2 reported with placebo.

Peripheral edema, muscular spasms, hypertension, acne, and headache were the most often reported treatment-emergent side effects during Nefecon therapy.

Reference:

Lafayette, R., Kristensen, J., Stone, A., Floege, J., Tesař, V., Trimarchi, H., Zhang, H., Reich, H. N., Rovin, B. H., & Barratt, J. (2023). Efficacy and safety of a targeted-release formulation of budesonide in patients with primary IgA nephropathy (NefIgArd): 2-year results from a randomised phase 3 trial. In The Lancet. Elsevier BV. https://doi.org/10.1016/s0140-6736(23)01554-4