Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy

Summary

The overall aim of the study is to evaluate the efficacy, safety, and tolerability of Nefecon 16 mg per day in the treatment of patients with primary IgAN (Immunoglobulin A nephropathy) at risk of progressing to end-stage renal disease (ESRD), despite maximum tolerated treatment with renin-angiotensin system (RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).

Timeline

Start

2018-09-05

Primary completion

2023-07-10

Completion

2023-07-10

Publications

• Background Fellstrom BC, Barratt J, Cook H, Coppo R, Feehally J, de Fijter JW, Floege J, Hetzel G, Jardine AG, Locatelli F, Maes BD, Mercer A, Ortiz F, Praga M, Sorensen SS, Tesar V, Del Vecchio L; NEFIGAN Trial Investigators. Targeted-release budesonide versus placebo in patients with IgA nephropathy (NEFIGAN): a double-blind, randomised, placebo-controlled phase 2b trial. Lancet. 2017 May 27;389(10084):2117-2127. doi: 10.1016/S0140-6736(17)30550-0. Epub 2017 Mar 28.
• Zhang H, Lafayette R, Wang B, Ying L, Zhu Z, Stone A, Kristensen J, Barratt J. Efficacy and Safety of Nefecon in Patients with IgA Nephropathy from Mainland China: 2-Year NefIgArd Trial Results. Kidney360. 2024 Dec 1;5(12):1881-1892. doi: 10.34067/KID.0000000583. Epub 2024 Oct 9.
• Lafayette R, Kristensen J, Stone A, Floege J, Tesar V, Trimarchi H, Zhang H, Eren N, Paliege A, Reich HN, Rovin BH, Barratt J; NefIgArd trial investigators. 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. Lancet. 2023 Sep 9;402(10405):859-870. doi: 10.1016/S0140-6736(23)01554-4. Epub 2023 Aug 14.
• Liao J, Zhou Y, Xu X, Huang K, Chen P, Wu Y, Jin B, Hu Q, Chen G, Zhao S. Current knowledge of targeted-release budesonide in immunoglobulin A nephropathy: A comprehensive review. Front Immunol. 2023 Jan 4;13:926517. doi: 10.3389/fimmu.2022.926517. eCollection 2022.
• Barratt J, Lafayette R, Kristensen J, Stone A, Cattran D, Floege J, Tesar V, Trimarchi H, Zhang H, Eren N, Paliege A, Rovin BH; NefIgArd Trial Investigators. 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. Epub 2022 Oct 19.

Drugs

Indications