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

Heerspink, H. J. L.; Agarwal, R.; Bakris, G. L.; Cherney, D. Z. I.; Lam, C. S. P.; Neuen, B. L.; Sarafidis, P. A.; Tuttle, K. R.; Wanner, C.; Brinker, M. D.; Dizayee, S.; Kolkhof, P.; Schloemer, P.; Vesterinen, P.; Perkovic, V.; Bittar, J.; Zaidman, C. J.; Cluigt, N.; Hominal, M.; Aguerre, P.; Halac, F.; Gelersztein, E.; Arriola, M.; Maldonado, R.; Chahin, M.; Packham, D.; Lee, D.; Pedagogos, E.; Foote, C.; Badve, S.; Hawley, C.; Chen, J.; Gray, N.; Speeckaert, M.; Labriola, L.; Doubel, P.; Maes, B.; Claes, K.; Dubois, B.; Dimitrova, I.; Vutova, T.; Ilchev, S.; Stamova, S.; Ivanova, Y.; Vasileva, A.; Chen, X.; Tang, S.; Xu, X.; Liu, B.; He, W.; He, Y.; Liu, F.; Wang, C.; Chen, L.; Niu, J.; Wang, D.; Luo, P.; Xia, Y.; Jiang, G.; Luo, Q.; Wang, F.; Chen, M.; Lin, H.; Yan, R.; Li, Y.; Chen, Q.; Dong, J.; Xiong, F.; Long, H.; Cheng, H.; Li, Y.; Du, J.; Liu, F.; Chen, Q.; Lu, W.; Chen, C.; Wang, J.; Liu, L.; Yang, M.; Long, G.; Shi, Y.; Li, W.; Yang, X.; Yang, A.; Li, J.; Meng, X.; Prazny, M.; Hornova, L.; Bucek, P.; Majernikova, M.; Wirth, J.; Rehorova, J.; Hornum, M.; Bech, J.; Lindhardt, M.; Hansen, D.; Mortensen, L.; Juhl, C.; Boletis, I.; Papadopoulou, D.; Papachristou, E.; Bamichas, G.; Petras, D.; Gouva, C.; Sarafidis, P.; Stylianou, K.; Ntounousi, E.; Tang, S. C. W.; Szeto, C. C.; Fung, S. K. S.; Lui, S. L.; Kovacs, L.; Nemeth, A.; Zilahi, Z.; Szelestei, T.; Kirschner, R.; Ignatius, A.; Almeida, A.; Sahay, M.; Arunkumar, S.; Khullar, D.; Pandey, R.; Ramanathan, S.; Gracious, N.; Mavani, S.; Levin-Iaina, N.; Rozen-Zvi, B.; Kruzel-Davila, E.; Haviv, Y.; Chetrit, S. B.; Beckerman, P.; Leiba, A.; Chernin, G.; Beberashvili, I.; Bassat, O. K. -B.; Kenig, Y.; Farber, E.; Ilieva, A. P.; Esposito, C.; Minutolo, R.; La Manna, G.; Santorelli, G.; Gregorini, M. C.; Donati, G.; Fiaccadori, E.; Gidaro, B.; Cimino, R.; Grandaliano, G.; Nakaya, I.; Maeda, Y.; Toda, T.; Okada, H.; Amemiya, M.; Suzuki, H.; Abe, M.; Nishi, H.; Kanno, Y.; Ueda, S.; Fujii, T.; Oshikawa, J.; Koizumi, M.; Tamura, K.; Yazawa, M.; Iwamoto, T.; Toyama, T.; Kitagawa, K.; Uchimura, K.; Kamijo, Y.; Ako, S.; Miyamoto, K.; Misaki, T.; Suzuki, S.; Shimizu, H.; Fujita, Y.; Ono, M.; Yamauchi, A.; Fujii, H.; Fujii, N.; Matsui, M.; Kidokoro, K.; Kanai, H.; Masutani, K.; Fujisaki, K.; Ishii, M.; Nakamura, M.; Toyoda, M.; Makita, Y.; Lee, L. Y.; Loh, C. L.; Yakob, S.; Ahmad, M. K.; Lee, K. Q.; Md Adnan, W. A. H. W.; Kader, M. A. S. A.; Ahmad, N. H.; Govindan, S.; Wahab, M. Z. A.; Mazlan, S. A. D.; Santana, S. I.; Wong, A. C.; Pardo, S. A.; Bayram, E.; Birne, R.; Teixeira E Costa, F.; Costa, J. S.; Alves, A. R.; Pereira, T.; Rodionova, T.; Antropenko, N.; Abissova, T.; Zhdanova, E.; Ezhov, A.; Suhail, S. M.; Liu, A.; Teo, J.; Yeo, S. C.; Tan, N. C.; Kim, S.; Lee, K. W.; Shin, S. J.; Han, B. -G.; Lee, J.; Han, S. Y.; Jang, H. R.; Lee, J. P.; Park, J. T.; Kang, Y. S.; Lee, S. Y.; Kim, Y. C.; Lee, S. H.; Park, H.; J. E., Oh; Kim, Y. H.; Choi, B. S.; Segura De La Morena, J. J.; Jaras, J. H.; Deben, F. M.; Bouarich, H.; Iborra, P. L.; Romero, M. S.; Teruel, J. G.; Castro, C.; Garrit, J. C.; Barrios, C.; Chiu, Y. -L.; Chen, H. -H.; Hung, C. -C.; Lin, S. -L.; Lee, C. -T.; M. -J., Wu; Chiu, P. -F.; Chang, C. -T.; Cheng, H. -T.; Mccafferty, K.; Griffin, S.; Smith, P.; Doulton, T.; Pickett, T.; Khwaja, A.; Alicic, R.; Alla, S.; Anand, S.; Atta, M.; Awad, A.; Bansal, S.; Burgner, A.; Chang, A.; Christiano, C.; Gupta, A.; Hernandez, G.; Jamal, A.; Kirk, E.; Kopyt, N.; Kotzker, W.; Mendez, R.; Meyer, J.; Mirkhel, A.; Newman, G.; Panse, S.; Pergola, P.; Rahman, M.; Rastogi, A.; Smith, M.; Turner, J.; Umpierrez, G.; Vo, N.; Schmidt, D.; Frome, A.; Nakhoul, G.; Ralph, R.; Tolins, J.; Kendrick, J.; Quadrini, M.; Elahi, S.; Manllo, S. T.; Chiang, W. -Y.; Moussa, J.; Thethi, T.

doi:10.1093/ndt/gfae132

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.