NefIgArd Part A pivotal phase III trial of Tarpeyo in IgA nephropathy published in Kidney International journal
Calliditas Therapeutics announced Kidney International has published the successful results from NefIgArd Part A, their pivotal Phase III, randomized, double-blind, placebo-controlled, multicenter study of Tarpeyo (budesonide enteric formulation)
The publication highlights the safety results and efficacy data related to both proteinuria and estimated glomerular filtration rate (eGFR) for patients treated with Tarpeyo while on background of optimized and stable renin-angiotensin system inhibitor (RASi) therapy.
At nine months, 24-hour urine protein-to-creatinine ratio (UPCR) was 27% lower in the Tarpeyo group compared with placebo, along with a benefit in eGFR preservation corresponding to a 3.87 ml/min/1.73 m2 difference versus placebo (both significant). Tarpeyo was well-tolerated, and treatment-emergent adverse events were mostly mild to moderate in severity and reversible. Part B is ongoing and will be reported on later. Thus, NefIgArd is the first phase III IgA nephropathy trial to show clinically important improvements in UPCR and eGFR and confirms the findings from the phase IIb NEFIGAN study.
See: "Results from part A of the multi-center, double-blind, randomized, placebo-controlled NefIgArd trial evaluated targeted-release formulation of budesonide for the treatment of primary immunoglobulin A nephropathy." Jonathan Barratt et al. Kidney International Published:October 18, 2022DOI:https://doi.org/10.1016/j.kint.2022.09.017
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