作者
Ilaria Gandolfini,Sara Alibrandi,Micaela Gentile,Luis Sanchez Russo,Enrico Fiaccadori,Alessandra Palmisano,Paolo Cravedi,Umberto Maggiore
摘要
We read with interest the results of the randomized Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy (NefIgArd) trial showing that, in patients with IgA nephropathy (IgAN), targeted-release budesonide (TR-budesonide) reduced proteinuria, compared with placebo. 1 Barratt J. Lafayette R. Kristensen 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; 103: 391-402 Abstract Full Text Full Text PDF PubMed Scopus (54) Google Scholar IgAN often recurs after transplant, and strategies for management of IgAN recurrence are less clear than they are in the primary forms. 2 Uffing A. Pérez-Sáez M.J. La Manna G. et al. A large, international study on post-transplant glomerular diseases: the TANGO project. BMC Nephrol. 2018; 19: 229 Crossref PubMed Scopus (19) Google Scholar ,3 Knoppova B. Reily C. King R.G. et al. Pathogenesis of IgA nephropathy: current understanding and implications for development of disease-specific treatment. J Clin Med. 2021; 10: 4501 Crossref PubMed Scopus (24) Google Scholar In a single-center retrospective study, we examined the timecourse of proteinuria and estimated glomerular filtration rate in 10 consecutive adult kidney transplant recipients with biopsy-proven IgAN recurrence who were treated with TR-budesonide (Ferring Pharmaceuticals) between January 2015 to January 2022 at the Parma University Hospital, Parma, Italy (see the Supplementary File for details and statistical analyses). 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 nephropathyKidney InternationalVol. 103Issue 2PreviewThe 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. Full-Text PDF Open AccessThe authors replyKidney InternationalVol. 103Issue 5PreviewGandolfini and colleagues have shared data on their experience using oral budesonide to treat recurrent IgA nephropathy (IgAN) after kidney transplantation in 10 patients.1 They found no benefit from the budesonide formulation used, and they suggest that although further study is needed, budesonide may have limited efficacy for IgAN post–kidney transplant. Although we agree that recurrent disease post-transplant may be worth investigating in a rigorous way, we suggest that these data be interpreted with a great deal of caution. Full-Text PDF