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, Parminder K Judge Renal Studies Group, Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford , Oxford , UK Search for other works by this author on: Oxford Academic Katherine R Tuttle Providence Inland Northwest Health, Spokane, WA and University of Washington , Seattle, WA , US Search for other works by this author on: Oxford Academic Natalie Staplin Renal Studies Group, Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford , Oxford , UK Search for other works by this author on: Oxford Academic Sibylle J Hauske Boehringer Ingelheim International GmbH , Ingelheim , Germany Vth Department of Medicine, University Medical Center Mannheim, Heidelberg University , Mannheim , Germany Search for other works by this author on: Oxford Academic Doreen Zhu Renal Studies Group, Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford , Oxford , UK Search for other works by this author on: Oxford Academic Rebecca Sardell Renal Studies Group, Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford , Oxford , UK Search for other works by this author on: Oxford Academic Lisa Cronin Boehringer Ingelheim International GmbH , Ingelheim , Germany Search for other works by this author on: Oxford Academic Jennifer B Green Search for other works by this author on: Oxford Academic Nikita Agrawal Renal Studies Group, Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford , Oxford , UK Search for other works by this author on: Oxford Academic Ryoki Arimoto Renal Studies Group, Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford , Oxford , UK Search for other works by this author on: Oxford Academic
https://orcid.org/0000-0002-2235-0103 , Kaitlin J Mayne Renal Studies Group, Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford , Oxford , UK School of Cardiovascular and Metabolic Health, College of Medical and Veterinary Life Sciences, University of Glasgow , Glasgow , UK Search for other works by this author on: Oxford Academic Emily Sammons Renal Studies Group, Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford , Oxford , UK Search for other works by this author on: Oxford Academic Martina Brueckmann Boehringer Ingelheim International GmbH , Ingelheim , Germany Ist Department of Medicine, University Medical Center Mannheim, Heidelberg University , Mannheim , Germany Search for other works by this author on: Oxford Academic Shimoli V Shah Boehringer Ingelheim International GmbH , Ingelheim , Germany Search for other works by this author on: Oxford Academic Peter Rossing Steno Diabetes Center Copenhagen , Copenhagen Denmark Department of Clinical Medicine, University of Copenhagen , Copenhagen , Denmark Search for other works by this author on: Oxford Academic Masaomi Nangaku Division of Nephrology and Endocrinology, University of Tokyo Hospital , Tokyo , Japan Search for other works by this author on: Oxford Academic Martin J Landray Renal Studies Group, Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford , Oxford , UK Search for other works by this author on: Oxford Academic Christoph Wanner Renal Studies Group, Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford , Oxford , UK University Clinic of Würzburg , Germany Search for other works by this author on: Oxford Academic Colin Baigent Renal Studies Group, Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford , Oxford , UK Search for other works by this author on: Oxford Academic Richard Haynes Renal Studies Group, Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford , Oxford , UK Search for other works by this author on: Oxford Academic William G Herrington Renal Studies Group, Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford , Oxford , UK Correspondence to: William G. Herrington; E-mail: cco.easikidney@ndph.ox.ac.ukwww.easikidney.org Search for other works by this author on: Oxford Academic
Nephrology Dialysis Transplantation, gfae263, https://doi.org/10.1093/ndt/gfae263
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12 November 2024
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Parminder K Judge, Katherine R Tuttle, Natalie Staplin, Sibylle J Hauske, Doreen Zhu, Rebecca Sardell, Lisa Cronin, Jennifer B Green, Nikita Agrawal, Ryoki Arimoto, Kaitlin J Mayne, Emily Sammons, Martina Brueckmann, Shimoli V Shah, Peter Rossing, Masaomi Nangaku, Martin J Landray, Christoph Wanner, Colin Baigent, Richard Haynes, William G Herrington, on behalf of the EASi-KIDNEY Steering Committee, The potential for improving cardio-renal outcomes in chronic kidney disease with the aldosterone synthase inhibitor vicadrostat (BI 690517): a rationale for the EASi-KIDNEY trial, Nephrology Dialysis Transplantation, 2024;, gfae263, https://doi.org/10.1093/ndt/gfae263
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Abstract
Patients with chronic kidney disease (CKD) are at risk of progressive loss of kidney function, heart failure, and cardiovascular death despite current proven therapies, including renin-angiotensin system inhibitors (RASi), sodium glucose co-transporter-2 inhibitors (SGLT2i), and statin-based regimens. RASi and SGLT2i reduce risk of CKD progression irrespective of primary cause of kidney disease, suggesting they target final common pathways. Targeting aldosterone overactivity with a nonsteroidal mineralocorticoid receptor antagonist (MRA) also reduces cardiorenal risk in patients with albuminuric diabetic kidney disease already treated with RASi. Together, these observations provide the rationale for trials to assess effects of inhibiting the aldosterone pathway in a broader range of patients with CKD, including those with non-diabetic causes of CKD or low albuminuria. Aldosterone synthase inhibitors (ASi) have emerged as an alternative to MRAs for aldosterone pathway inhibition. Phase II data from 586 patients with albuminuric CKD have shown that 10 mg of an ASi, vicadrostat (BI 690517), reduced urine albumin-to-creatinine ratio by ∼40% compared to placebo with or without concurrent empagliflozin treatment. MRA and ASi increase risk of hyperkalaemia. Combining their use with an SGLT2i may mitigate some of this risk, improving tolerability, and allowing a wider range of patients to be treated (including those with higher levels of blood potassium than in previous trials). The EASi-KIDNEY (NCT06531824) double-blind placebo-controlled trial will test this approach by assessing the safety and cardiorenal efficacy of vicadrostat in combination with empagliflozin in ∼11,000 patients with CKD. It will be sufficiently large to assess effects in patients with and without diabetes separately.
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aldosterone, cardiovascular, CKD, clinical trial, heart failure
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© The Author(s) 2024. Published by Oxford University Press on behalf of the ERA.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
Topic:
- aldosterone
- aldosterone synthase
- kidney failure, chronic
- heart failure
- kidney
- addiction severity index
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Original Article
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