학술논문
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
Document Type
Article
Author
Barratt, Jonathan; Lafayette, Richard; Kristensen, Jens; Stone, Andrew; Cattran, Daniel; Floege, Jürgen; Tesar, Vladimir; Trimarchi, Hernán; Zhang, Hong; Eren, Necmi; Paliege, Alexander; Rovin, Brad H.; Fragale, Guillermo; Karl, Alejandra; Losisolo, Patricia; Trimarchi, Hernán; Hoyos, Ivan Gonzalez; Lampo, Mauro Guillermo; Monkowski, Matias; De La Fuente, Jorge; Alvarez, Magdalena; Stoppa, Daniela; Chiurchiu, Carlos; Novoa, Pablo Antonio; Orias, Marcelo; Barron, Maria Belen; Giotto, Ana; Arriola, Mariano; Cassini, Evelin; Maldonado, Rafael; Dionisi, Maria Paula; Ryan, Jessica; Toussaint, Nigel; Luxton, Grant; Peh, Chen Au; Levidiotis, Vicki; Francis, Ross; Phoon, Richard; Fedosiuk, Elena; Toropilov, Dmitry; Yakubtsevich, Ruslan; Mikhailova, Elena; Bovy, Christophe; Demoulin, Nathalie; Hougardy, Jean-Michel; Maes, Bart; Speeckaert, Marijn; Laurin, Louis-Philippe; Barbour, Sean; Masse, Melanie; Hladunewich, Michelle; Reich, Heather; Cournoyer, Serge; Tennankore, Karthik; Barbour, Sean; Lv, Jicheng; Liu, Zhangsuo; Wang, Caili; Li, Shaomei; Luo, Qun; Ni, Zhaohui; Yan, Tiekun; Fu, Ping; Cheng, Hong; Liu, Bicheng; Lu, Wanhong; Wang, Jianqin; Chen, Qinkai; Wang, DeGuang; Xiong, Zuying; Chen, Menghua; Xu, Yan; Wei, Jiali; Pai, Pearl; Chen, Lianhua; Rehorova, Jitka; Maixnerova, Dita; Safranek, Roman; Rychlik, Ivan; Hruby, Miroslav; Makela, Satu; Vaaraniemi, Kati; Ortiz, Fernanda; Alamartine, Eric; Daroux, Maite; Cartery, Claire; Vrtovsnik, Francois; Serre, Jean-Emmanuel; Stamellou, Eleni; Vielhauer, Volker; Hugo, Christian; Budde, Klemens; Otte, Britta; Nitschke, Martin; Ntounousi, Evangelia; Boletis, Ioannis; Papagianni, Aikaterini; Goumenos, Dimitrios; Stylianou, Konstantinos; Zermpala, Synodi; Esposito, Ciro; Cozzolino, Mario Gennaro; Viganò, Sara Maria; Gesualdo, Loreto; Nowicki, Michal; Stompor, Tomasz; Kurnatowska, Ilona; Kim, Sung Gyun; Kim, Yong-Lim; Na, Ki-Ryang; Kim, Dong Ki; Kim, Su-Hyun; Porras, Luis Quintana; Garcia, Eva Rodriguez; Pamplona, Irene Agraz; Segarra, Alfons; Goicoechea, Marian; Fellstrom, Bengt; Lundberg, Sigrid; Hemmingsson, Peter; Guron, Gregor; Sandell, Anna; Chen, Cheng-Hsu; Tokgoz, Bulent; Duman, Soner; Altiparmak, Mehmet Riza; Ergul, Metin; Maxwell, Peter; Mark, Patrick; McCafferty, Kieran; Khwaja, Arif; Cheung, Chee Kay; Hall, Matthew; Power, Albert; Kanigicherla, Durga; Baker, Richard; Moriarty, Jim; Mohamed, Amr; Aiello, Joseph; Canetta, Pietro; Ayoub, Isabelle; Robinson, Derrick; Thakar, Surabhi; Mottl, Amy; Sachmechi, Isaac; Fischbach, Bernard; Singh, Harmeet; Mulhern, Jeffrey; Kamal, Fahmeedah; Linfert, Douglas; Rizk, Dana; Wadhwani, Shikha; Sarav, Menaka; Campbell, Kirk; Coppock, Gaia; Luciano, Randy; Sedor, John; Avasare, Rupali; Lau, Wai Lang
Source
Kidney International; February 2023, Vol. 103 Issue: 2 p391-402, 12p
Subject
Language
ISSN
00852538; 15231755
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 m2difference 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.