Results from part A of the multi-center, double-blind, randomized, placebo-controlled NefIgArd trial, which evaluated targeted-release formulation of budesonide for the treatment of primary immunoglobulin A nephropathy
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- dc.contributor.author Barratt, Jonathan
- dc.contributor.author Lafayette, Richard
- dc.contributor.author Kristensen, Jens
- dc.contributor.author Stone, Andrew
- dc.contributor.author Cattran, Daniel
- dc.contributor.author Floege, Jürgen
- dc.contributor.author Tesar, Vladimir
- dc.contributor.author Trimarchi, Hernán
- dc.contributor.author Zhang, Hong
- dc.contributor.author Eren, Necmi
- dc.contributor.author Paliege, Alexander
- dc.contributor.author Rovin, Brad H.
- dc.contributor.author NefIgArd Trial Investigators
- dc.date.accessioned 2024-02-13T09:20:50Z
- dc.date.available 2024-02-13T09:20:50Z
- dc.date.issued 2023
- dc.description.abstract 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.
- dc.format.mimetype application/pdf
- dc.identifier.citation Barratt J, Lafayette R, Kristensen J, Stone A, Cattran D, Floege J, et al. Results from part A of the multi-center, double-blind, randomized, placebo-controlled NefIgArd trial, which evaluated targeted-release formulation of budesonide for the treatment of primary immunoglobulin A nephropathy. Kidney Int. 2023 Feb;103(2):391-402. DOI: 10.1016/j.kint.2022.09.017
- dc.identifier.doi http://dx.doi.org/10.1016/j.kint.2022.09.017
- dc.identifier.issn 0085-2538
- dc.identifier.uri http://hdl.handle.net/10230/59093
- dc.language.iso eng
- dc.publisher Elsevier
- dc.relation.ispartof Kidney Int. 2023 Feb;103(2):391-402
- dc.rights © 2022 Published by Elsevier, Inc., on behalf of the International Society of Nephrology. This article is available under the Creative Commons CC-BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/) and permits non-commercial use of the work as published, without adaptation or alteration provided the work is fully attributed.
- dc.rights.accessRights info:eu-repo/semantics/openAccess
- dc.rights.uri http://creativecommons.org/licenses/by-nc-nd/4.0/
- dc.subject.keyword IgA nephropathy
- dc.subject.keyword Glomerular disease
- dc.subject.keyword Glucocorticoids
- dc.subject.keyword Gut-associated lymphoid tissue
- dc.title Results from part A of the multi-center, double-blind, randomized, placebo-controlled NefIgArd trial, which evaluated targeted-release formulation of budesonide for the treatment of primary immunoglobulin A nephropathy
- dc.type info:eu-repo/semantics/article
- dc.type.version info:eu-repo/semantics/publishedVersion