The therapeutic potential of a novel, targeted-release formulation of oral budesonide (Nefecon) for the treatment of IgA nephropathy (IgAN) was first demonstrated by the phase 2b NEFIGAN trial. To verify these findings, the phase 3 NefigArd trial tested the efficacy and safety of nine months of treatment with Nefecon (16 mg/d) versus placebo in adult patients with primary IgAN at risk of progressing to kidney failure (ClinicalTrials.gov: NCT03643965). NefIgArd was a multicenter, randomized, double-blind, placebo-controlled two-part trial. In Part A, 199 patients with IgAN were treated with Nefecon or placebo for nine months and observed for an additional three months. The primary endpoint for Part A was 24-hour urine protein-to-creatinine ratio (UPCR) after nine months. Secondary efficacy outcomes evaluated included estimated glomerular filtration rate (eGFR) at nine and 12 months and the UPCR at 12 months. At nine months, UPCR was 27% lower in the Nefecon 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). Nefecon 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 3 IgA nephropathy trial to show clinically important improvements in UPCR and eGFR and confirms the findings from the phase 2b NEFIGAN study.

Calliditas Therapeutics AB Stockholm Sweden

College of Medicine Biological Sciences and Psychology University of Leicester Leicester UK

Department of Nephrology 1st School of Medicine and General University Hospital Charles University Prague Czech Republic

Department of Nephrology and Clinical Immunology Rheinisch Westfälische Technische Hochschule Aachen University Hospital Aachen Germany

Department of Nephrology Kocaeli University Kocaeli Turkey

Division of Nephrology Department of Internal Medicine 3 University Hospital Carl Gustav Carus at the Technische Universität Dresden Dresden Germany

Division of Nephrology Department of Medicine Stanford University Stanford California USA

Division of Nephrology the Ohio State University Wexner Medical Center Columbus Ohio USA

Division of Nephrology Toronto General Hospital Research Institute University of Toronto Toronto Ontario Canada

Nephrology Service Hospital Británico de Buenos Aires Buenos Aires Argentina

Renal Division Peking University 1st Hospital Peking University Institute of Nephrology Beijing China

Stone Biostatistics Ltd Crewe UK

Kidney Int. 2023 Feb;103(2):258-261. doi: 10.1016/j.kint.2022.10.019. PubMed

Kidney Int. 2023 May;103(5):994. doi: 10.1016/j.kint.2023.02.011. PubMed

Kidney Int. 2023 May;103(5):995-996. doi: 10.1016/j.kint.2023.02.012. PubMed

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IgA nephropathy

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ClinicalTrials.gov
NCT03643965