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
Author:
Heerspink Hiddo J L1ORCID, Agarwal Rajiv2, Bakris George L3, Cherney David Z I4, Lam Carolyn S P56, Neuen Brendon L78ORCID, Sarafidis Pantelis A9ORCID, Tuttle Katherine R1011ORCID, Wanner Christoph12ORCID, Brinker Meike D13, Dizayee Sara14, Kolkhof Peter15ORCID, Schloemer Patrick16, Vesterinen Paula17, Perkovic Vlado7, , Bittar Julio, Zaidman Cesar Javier, Cluigt Natalia, Hominal Miguel, Aguerre Paola, Halac Fernando, Gelersztein Elizabeth, Arriola Mariano, Maldonado Rafael, Chahin Mariano, Packham David, Lee Darren, Pedagogos Eugenia, Foote Celine, Badve Sunil, Hawley Carmel, Chen Jenny, Gray Nicholas, Speeckaert Marijn, Labriola Laura, Doubel Peter, MAES Bart, Claes Kathleen, Dubois Bernard, Dimitrova Irena, Vutova Tsvetelina, Ilchev Stefan, Stamova Svetla, Ivanova Yordanka, Vasileva Albena, Chen Xiangmei, Tang Shuifu, Xu Xudong, Liu Bicheng, He Weiming, He Yani, Liu Fang, Wang Caili, Chen Lianhua, Niu Jianying, Wang Deguang, Luo Ping, Xia Yuou, Jiang Gengru, Luo Qun, Wang Fang, Chen Menghua, Lin Hongli, Yan Rui, Li Yinan, Chen Qinkai, Dong Junwu, Xiong Fei, Long Haibo, Cheng Hong, Li Yuehong, Du Juan, Liu Fanna, Chen Qingping, Lu Wanhong, Chen Chaosheng, Wang Jianqin, Liu Lei, Yang Min, Long Gang, Shi Yongjun, Li Wenge, Yang Xiangdong, Yang Aicheng, Li Jianfei, Meng Xiaoyan, Prazny Martin, Hornova Lucie, Bucek Petr, Majernikova Maria, Wirth Jan, Rehorova Jitka, Hornum Mads, Bech Jesper, Lindhardt Morten, Hansen Ditte, Mortensen Line, Juhl Claus, Boletis Ioannis, Papadopoulou Dorothea, Papachristou Evangelos, Bamichas Gerasimos, Petras Dimitrios, Gouva Chariklia, Sarafidis Pantelis, Stylianou Konstantinos, Ntounousi Evangelia, Tang Sydney Chi Wai, Szeto Cheuk Chun, Fung Samuel Ka Shun, Lui Sing Leung, Kovacs Laszlo, Nemeth Aniko, Zilahi Zsolt, Szelestei Tamas, Kirschner Robert, Ignatius Avinash, Almeida Alan, Sahay Manisha, Arunkumar Subbiah, Khullar Dinesh, Pandey Rajendra, Ramanathan Sakthirajan, Gracious Noble, Mavani Siddharth, Levin-Iaina Nomy, Rozen-Zvi Benaya, Kruzel-Davila Etty (Esther), Haviv Yosef, Chetrit Sydney Ben, Beckerman Pazit, Leiba Adi, Chernin Gil, Beberashvili Illia, Bassat Orit Kliuk-Ben, Kenig Yael, Farber Evgeny, Ilieva Aneliya Parvanova, Esposito Ciro, Minutolo Roberto, La Manna Gaetano, Santorelli Gennaro, Gregorini Maria Cristina, Donati Gabriele, Fiaccadori Enrico, Gidaro Barbara, Cimino Roberto, Grandaliano Giuseppe, Nakaya Izaya, Maeda Yoshitaka, Toda Takayuki, Okada Hirokazu, Amemiya Morimasa, Suzuki Hitoshi, Abe Masanori, Nishi Hiroshi, Kanno Yoshihiko, Ueda Seiji, Fujii Tetsuro, Oshikawa Jin, Koizumi Masahiro, Tamura Koichi, Yazawa Masahiko, Iwamoto Tamio, Toyama Tadashi, Kitagawa Kiyoki, Uchimura Kohei, Kamijo Yuji, Ako Shinji, Miyamoto Kanyu, Misaki Taro, Suzuki Satoshi, Shimizu Hideaki, Fujita Yoshiro, Ono Minamo, Yamauchi Atsushi, Fujii Hideki, Fujii Naohiko, Matsui Masaru, Kidokoro Kengo, Kanai Hidetoshi, Masutani Kosuke, Fujisaki Kiichiro, Ishii Masao, Nakamura Megumi, Toyoda Mariko, Makita Yuichiro, Lee Li Yuan, Loh Chek Loong, Yakob Suryati, Ahmad Mohd Kamil, Lee Kai Quan, Adnan Wan Ahmad Hafiz Wan Md, Kader Muhamad Ali Sk Abdul, Ahmad Nuzaimin Hadafi, Govindan Subasni, Wahab Mohamad Zaimi Abdul, Mazlan Sadanah Aqashiah Datuk, Santana Sergio Irizar, Wong Alfredo Chew, Pardo Sandro Avila, Bayram Edmundo, Birne Rita, Teixeira e Costa Fernando, Costa Joana Silva, Alves Ana Rita, Pereira Tiago, Rodionova Tatyana, Antropenko Natalia, Abissova Tatyana, Zhdanova Elena, Ezhov Andrey, Suhail Sufi Muhummad, Liu Allen, Teo Jimmy, Yeo See Cheng, Tan Ngiap Chuan, Kim SungGyun, Lee Kang Wook, Shin Seok Joon, Han Byoung-Geun, Lee Jangwook, Han Sang Youb, Jang Hye Ryoun, Lee Jung Pyo, Park Jung Tak, Kang Young Sun, Lee So Young, Kim Yong Chul, Lee Sang Ho, Park Hayne, Oh Ji Eun, Kim Yeong Hoon, Choi Bum Soon, Segura de la Morena Jose Julian, Jaras Julio Hernandez, Debén Francisco Martínez, Bouarich Hanane, Iborra Pau Llacer, Romero María Soler, Teruel Jose Gorriz, Castro Cristina, Garrit Josep Cruzado, Barrios Clara, Chiu Yen-Ling, Chen Hsi-Hsien, Hung Cheng-Chieh, Lin Shuei-Liong, Lee Chien-Te, Wu Ming-Ju, Chiu Ping-Fang, Chang Chiz-Tzung, Cheng Hui-Teng, McCafferty Kieran, Griffin Siân, Smith Priscilla, Doulton Tim, Pickett Thomas, Khwaja Arif, Alicic Radica, Alla Sreedhara, Anand Sanjiv, Atta Mohamed, Awad Ahmed, Bansal Shweta, Burgner Anna, Chang Alex, Christiano Cynthia, Gupta Aditi, Hernandez German, Jamal Aamir, Kirk Eric, Kopyt Nelson, Kotzker Wayne, Mendez Ramon, Meyer Jill, Mirkhel Ahmadshah, Newman George, Panse Sagar, Pergola Pablo, Rahman Mahboob, Rastogi Anjay, Smith Mark, Turner Jeffrey, Umpierrez Guillermo, Vo Nam, Schmidt Darren, Frome Adam, Nakhoul George, Ralph Ronald, Tolins Jonathan, Kendrick Jessica, Quadrini Michael, Elahi Sadaf, Manllo Sergio Trevino, Chiang Wen-Yuan, Moussa Jany, Thethi Tina
Affiliation:
1. Department of Clinical Pharmacy and Pharmacology, University of Groningen , Groningen , The Netherlands 2. Division of Nephrology, Department of Medicine, Indiana University School of Medicine and RL Roudebush VA Medical Center , Indianapolis, IN , USA 3. Department of Medicine, AHA Comprehensive Hypertension Center, University of Chicago Medicine , Chicago, IL , USA 4. Department of Medicine, Division of Nephrology, University Health Network , Toronto, ON , Canada 5. National Heart Centre Singapore , Singapore , Singapore 6. Duke-National University of Singapore Medical School , Singapore , Singapore 7. Renal and Metabolic Division, George Institute for Global Health, University of New South Wales , Sydney, New South Wales , Australia 8. Department of Renal Medicine, Royal North Shore Hospital , Sydney, New South Wales , Australia 9. 1st Department of Nephrology, Aristotle University of Thessaloniki, Hippokration Hospital , Thessaloniki , Greece 10. Providence Inland Northwest Health , Spokane, WA , USA 11. Nephrology Division and Kidney Research Institute, University of Washington School of Medicine , Seattle, WA , USA 12. Department of Clinical Research and Epidemiology, Comprehensive Heart Failure Center, University of Würzburg , Würzburg , Germany 13. Cardiology and Nephrology Clinical Development , Bayer AG, Wuppertal , Germany 14. Regulatory Strategy Cardiology and Nephrology , Bayer AG, Wuppertal , Germany 15. Cardiovascular Precision Medicines, Research and Development , Bayer AG, Wuppertal , Germany 16. Clinical Statistics & Analytics, Research and Development , Bayer AG, Berlin , Germany 17. Medical and Scientific Affairs, Bayer Pharmaceuticals , Espoo , Finland
Abstract
ABSTRACT
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 study treatment. The most common causes of CKD were chronic glomerulonephritis (57.0%) and hypertensive/ischaemic nephropathy (29.0%). Immunoglobulin A nephropathy was the most common glomerulonephritis (26.3% of the total population). At baseline, mean eGFR and median UACR were 46.7 ml/min/1.73 m2 and 818.9 mg/g, respectively. Diuretics were used by 282 participants (17.8%), statins by 851 (53.7%) and calcium channel blockers by 794 (50.1%). Sodium–glucose co-transporter 2 (SGLT2) inhibitors were used in 16.9% of patients; these individuals had a similar mean eGFR (45.6 versus 46.8 ml/min/1.73 m2) and a slightly higher median UACR (871.9 versus 808.3 mg/g) compared with those not using SGLT2 inhibitors at baseline.
Conclusions
FIND-CKD is the first phase 3 trial of finerenone in patients with CKD of non-diabetic aetiology.
Publisher
Oxford University Press (OUP)
Cited by
5 articles.
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