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
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
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.