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Design and baseline characteristics of the Finerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease (FIND-CKD) randomized trial

作者:Hiddo J.L. Heerspink, Rajiv Agarwal, George L. Bakris, David Z.I. Cherney, Carolyn S.P. Lam, Brendon L. Neuen, Pantelis Sarafidis, Katherine R. Tuttle, Christoph Wanner, Meike Brinker, Sara Dizayee, Peter Kolkhof, Patrick Schloemer, Paula Vesterinen, Vlado Perkovic, for the FIND-CKD investigators, Julio Bittar, Cesar Javier Zaidman, Natalia Cluigt, Miguel Hominal, Paola Aguerre, Fernando Halac, Elizabeth Gelersztein, M. Arriola, Rafaël Maldonado, Mariano Chahin, David Packham, Darren J. Lee, Eugenia Pedagogos, Celine Foote, Sunil V. Badve, Carmel M. Hawley, Jenny Chen, Nicholas A. Gray, Marijn M. Speeckaert, Laura Labriola, Peter Doubel, Bart Maes, Kathleen Claes, Bernard Dubois, Irena Dimitrova, Tsvetelina Vutova, Stefan Ilchev, Svetla Stamova, Yordanka Ivanova, А М Васильева, Xiangmei Chen, Shuifu Tang, Xudong Xu, Bi‐Cheng Liu, Weiming He, Yani He, Fang Liu, Caili Wang, Lianhua Chen, Jianying Niu, Deguang Wang, Ping Luo, Yuou Xia, Gengru Jiang, Qun Luo, Fang Wang, Menghua Chen, Hongli Lin, Rui Yan, Yinan Li, Qinkai Chen, Junwu Dong, Fei Xiong, Haibo Long, Hong Cheng, Yuehong Li, Juan Du, Fanna Liu, Qingping Chen, Wanhong Lu, Chaosheng Chen, Jianqin Wang, Lei Liu, Min Yang, Gang Long, Yongjun Shi, Wenge Li, Xiangdong Yang, Aicheng Yang, Jianfei Li, Xiaoyan Meng, Martin Prázný, Lucie Hornova, Petr Bucek, Mária Majerníková, Jan Wirth, Jitka Řehořová, Mads Hornum, Jesper Nørgaard Bech, Morten Lindhardt, Ditte Hansen, Line Mortensen, Claus Bogh Juhl, Ioannis Boletis, Dorothea Papadopoulou, Evangelos Papachristou, Gerasimos Bamichas, Dimitrios Petras, Chariklia Gouva, Pantelis Sarafidis, Kostas Stylianou, Evangelia Ntounousi, Sydney Tang, Cheuk‐Chun Szeto, Samuel Fung, Sing Leung Lui, László Kovács, Aniko Nemeth, Z Zilahi, T Szelestei, Róbert Kirschner, Avinash Ignatius, Alan Almeida, Manisha Sahay, S Arunkumar, Dinesh Khullar, Rajendra Pandey, Ramanathan Sakthirajan, Noble Gracious, Siddharth Mavani, Nomy Levin-Iaina, Benaya Rozen‐Zvi, Etty Kruzel-Davila, Yosef S. Haviv, Sydney Ben Chetrit, Pazit Beckerman, Adi Leiba, Gil Chernin, Illia Beberashvili, Orit Kliuk‐Ben Bassat, Yael Kenig, Evgeny Farber, Aneliya Parvanova Ilieva, Ciro Esposito, Roberto Minutolo, Gaetano La Manna, Gennaro Santorelli, Maria Cristina Gregorini, Gabriele Donati, Enrico Fiaccadori, Barbara Gidaro, R Cimino, Giuseppe Grandaliano, Izaya Nakaya, Yoshitaka Maeda, Takayuki Toda, Hirokazu Okada, Morimasa Amemiya, Hitoshi Suzuki, Masanori Abe, Hiroshi Nishi, Yoshihiko Kanno, Seiji Ueda, Tetsuro Fujii, Jin Oshikawa, Masahiro Koizumi, Koichi Tamura, Masahiko Yazawa, Tamio Iwamoto, Tadashi Toyama, Kiyoki Kitagawa, Kohei Uchimura, Yuji Kamijo, Shinji Ako, Kanyu Miyamoto, Taro Misaki, Satoshi Suzuki, Hideaki Shimizu, Yoshiro Fujita, Minamo Ono, Atsushi Yamauchi, Hideki Fujii, Naohiko Fujii, Masaru Matsui, Kengo Kidokoro, Hidetoshi Kanai, Kosuke Masutani, Kiichiro Fujisaki, Masao Ishii, Megumi Nakamura, Mariko Toyoda, Yuichiro Makita, Li Yuan Lee, Chek Loong Loh, S. Yakob, Mohd Kamil Ahmad, K. Lee, Wan Ahmad Hafiz Wan Md Adnan, Muhamad Ali SK Abdul Kader, Nuzaimin Hadafi Ahmad, Subasni Govindan, Mohamad Zaimi Abdul Wahab, Sadanah Aqashiah Mazlan, Sergio Irizar Santana, Alfredo Chew Wong, Sandro Avila Pardo, Edmundo Bayram, Rita Birne, Fernando Teixeira e Costa, Joana Silva Costa, Ana Rita Alves, Tiago Pereira, Tatyana Rodionova, Natalia Antropenko, Т. О. Абиссова, Elena Zhdanova, Andrey Ezhov, Sufi Muhummad Suhail, Allen Liu, Jimmy Teo, See Cheng Yeo, Ngiap Chuan Tan, SungGyun Kim, Kang Wook Lee, Seok Joon Shin, Byoung Geun Han, Jangwook Lee, Sang Youb Han, Hye Ryoun Jang, Jung Pyo Lee, Jung Tak Park, Young Sun Kang, So Young Lee, Yong Chul Kim, Sang Ho Lee, Hayne Park, Ji Eun Oh, Yeong Hoon Kim, Bum Soon Choi, José Julián Segura de la Morena, Julio Hernández Jaras, Francisco Martínez Debén, Hanane Bouarich, Pau Llácer Iborra, María Soler Romero, Jose Gorriz Teruel, Cristina Castro, Josep Cruzado Garrit, Clara Barrios, Yen‐Ling Chiu, Hsi-Hsien Chen, Cheng-Chieh Hung, Shuei‐Liong Lin, Chien‐Te Lee, Ming-Ju Wu, Ping‐Fang Chiu, Chiz‐Tzung Chang, Hui‐Teng Cheng, Kieran McCafferty, Siân Griffin, Priscilla Smith, Tim Doulton, T Pickett, Arif Khwaja, Radica Z. Alicic, Sreedhara Alla, Sanjiv Anand, Mohamed G. Atta, Ahmed K. Awad, Shweta Bansal, Anna Burgner, Alex R. Chang, Cynthia Christiano, Aditi Gupta, German Hernandez, Aamir Jamal, Eric A. Kirk, Nelson Kopyt, Wayne Kotzker, Ramón Méndez, Jill Meyer, Ahmadshah Mirkhel, George Newman, Sagar Panse, Pablo E. Pérgola, Mahboob Rahman, Anjay Rastogi, Mark Smith, Jeffrey M. Turner, Guillermo E. Umpierrez, Nam S. Vo, Darren W. Schmidt, Adam Frome, George Nakhoul, R. Scott Ralph, J P Tolins, Jessica Kendrick, Michael Quadrini, Sadaf Elahi, Sergio Trevino Manllo, Wen‐Yuan Chiang, Jany Moussa, Tina K. Thethi · 发表于:Nephrology Dialysis Transplantation · 年份:2024 · DOI:10.1093/ndt/gfae132 · 被引用次数:85 · 研究领域:Hormonal Regulation and Hypertension、Blood Pressure and Hypertension Studies、Adrenal Hormones and Disorders

BACKGROUND: Finerenone, a non-steroidal mineralocorticoid receptor antagonist, improved kidney and cardiovascular outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes in two phase 3 outcome trials. The Finerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease (FIND-CKD) study investigates the effect of finerenone in adults with CKD without diabetes. METHODS: FIND-CKD (NCT05047263 and EU CT 2023-506897-11-00) is a randomized, double-blind, placebo-controlled phase 3 trial in patients with CKD of non-diabetic aetiology. Adults with a urinary albumin:creatinine ratio (UACR) ≥200-≤3500 mg/g and an estimated glomerular filtration rate (eGFR) ≥25-<90 ml/min/1.73 m2 receiving a maximum tolerated dose of a renin-angiotensin system inhibitor were randomized 1:1 to once-daily placebo or finerenone 10 or 20 mg depending on eGFR >60 or <60 ml/min/1.73 m2. The primary efficacy outcome is total eGFR slope, defined as the mean annual rate of change in eGFR from baseline to month 32. Secondary efficacy outcomes include a combined cardiorenal composite outcome comprising time to kidney failure, sustained ≥57% decrease in eGFR, hospitalization for heart failure or cardiovascular death, as well as separate kidney and cardiovascular composite outcomes. Adverse events are recorded to assess tolerability and safety. RESULTS: Across 24 countries, 3231 patients were screened and 1584 were randomized to...