Safety and efficacy of sodium zirconium cyclosilicate for the management of acute and chronic hyperkalemia in children with chronic kidney disease 4–5 and on dialysis

Kovesdy CP, Matsushita K, Sang Y, Brunskill NJ, Carrero JJ, Chodick G, Hasegawa T, Heerspink HL, Hirayama A, Landman GWD, Levin A, Nitsch D, Wheeler DC, Coresh J, Hallan SI, Shalev V, Grams ME, CKD Prognosis Consortium (2018) Serum potassium and adverse outcomes across the range of kidney function: a CKD Prognosis Consortium meta-analysis. Eur Heart J 39:1535–1542

Article  CAS  PubMed  PubMed Central  Google Scholar 

Kurzinski KL, Xu Y, Ng DK, Furth SL, Schwartz GJ, Warady BA, CKiD Study Investigators (2023) Hyperkalemia in pediatric chronic kidney disease. Pediatr Nephrol 38:3083–3090

Article  PubMed  PubMed Central  Google Scholar 

Belmar Vega L, Galabia ER, Bada da Silva J, Bentanachs Gonzalez M, Fernandez Fresnedo G, Pinera Haces C, Palomar Fontanet R, Ruiz San Millan JC, de Francisco ALM (2019) Epidemiology of hyperkalemia in chronic kidney disease. Nefrologia (Engl Ed) 39:277–286

Article  PubMed  Google Scholar 

Desloovere A, Renken-Terhaerdt J, Tuokkola J, Shaw V, Greenbaum LA, Haffner D, Anderson C, Nelms CL, Oosterveld MJS, Paglialonga F, Polderman N, Qizalbash L, Warady BA, Shroff R, Vande Walle J (2021) The dietary management of potassium in children with CKD stages 2–5 and on dialysis-clinical practice recommendations from the Pediatric Renal Nutrition Taskforce. Pediatr Nephrol 36:1331–1346

Article  PubMed  PubMed Central  Google Scholar 

Laureati P, Xu Y, Trevisan M, Schalin L, Mariani I, Bellocco R, Sood MM, Barany P, Sjolander A, Evans M, Carrero JJ (2020) Initiation of sodium polystyrene sulphonate and the risk of gastrointestinal adverse events in advanced chronic kidney disease: a nationwide study. Nephrol Dial Transplant 35:1518–1526

Article  CAS  PubMed  Google Scholar 

Borrelli S, Matarazzo I, Lembo E, Peccarino L, Annoiato C, Scognamiglio MR, Foderini A, Ruotolo C, Franculli A, Capozzi F, Yavorskiy P, Merheb F, Provenzano M, La Manna G, De Nicola L, Minutolo R, Garofalo C (2022) Chronic hyperkaliemia in chronic kidney disease: an old concern with new answers. Int J Mol Sci 23:6378

Article  CAS  PubMed  PubMed Central  Google Scholar 

Levien TL, Baker DE (2019) Sodium Zirconium Cyclosilicate. Hosp Pharm 54:12–19

Article  PubMed  Google Scholar 

Dong L, Xu W, Deng Y, Tan J, Qin W (2022) Efficacy and safety of potassium binders in the treatment of patients with chronic kidney disease and hyperkalemia. Eur J Pharmacol 931:175174

Article  CAS  PubMed  Google Scholar 

Packham DK, Rasmussen HS, Lavin PT, El-Shahawy MA, Roger SD, Block G, Qunibi W, Pergola P, Singh B (2015) Sodium zirconium cyclosilicate in hyperkalemia. N Engl J Med 372:222–231

Article  PubMed  Google Scholar 

Kim K, Fagerstrom J, Chen G, Lagunova Z, Furuland H, McEwan P (2022) Cost effectiveness of sodium zirconium cyclosilicate for the treatment of hyperkalaemia in patients with CKD in Norway and Sweden. BMC Nephrol 23:281

Article  PubMed  PubMed Central  Google Scholar 

Kosiborod M, Rasmussen HS, Lavin P, Qunibi WY, Spinowitz B, Packham D, Roger SD, Yang A, Lerma E, Singh B (2014) Effect of sodium zirconium cyclosilicate on potassium lowering for 28 days among outpatients with hyperkalemia: the HARMONIZE randomized clinical trial. JAMA 312:2223–2233

Article  PubMed  Google Scholar 

Fishbane S, Ford M, Fukagawa M, McCafferty K, Rastogi A, Spinowitz B, Staroselskiy K, Vishnevskiy K, Lisovskaja V, Al-Shurbaji A, Guzman N, Bhandari S (2019) A phase 3b, randomized, double-blind, placebo-controlled study of sodium zirconium cyclosilicate for reducing the incidence of predialysis hyperkalemia. J Am Soc Nephrol 30:1723–1733

Article  CAS  PubMed  PubMed Central  Google Scholar 

Liu B, Wang T, Chen Z (2022) Sodium zirconium cyclosilicate pretreatment for formula in vitro reduces potassium intake in infants with chronic kidney disease. Chin Med J (Engl) 135:3007–3009

Article  CAS  PubMed  Google Scholar 

Ash SR, Singh B, Lavin PT, Stavros F, Rasmussen HS (2015) A phase 2 study on the treatment of hyperkalemia in patients with chronic kidney disease suggests that the selective potassium trap, ZS-9, is safe and efficient. Kidney Int 88:404–411

Article  CAS  PubMed  PubMed Central  Google Scholar 

Flynn JT, Kaelber DC, Baker-Smith CM, Blowey D, Carroll AE, Daniels SR, de Ferranti SD, Dionne JM, Falkner B, Flinn SK, Gidding SS, Goodwin C, Leu MG, Powers ME, Rea C, Samuels J, Simasek M, Thaker VV, Urbina EM, Subcommittee on Screening and Management of High Blood Pressure in Children (2017) Clinical practice guideline for screening and management of high blood pressure in children and adolescents. Pediatrics 140:e20171904

Article  PubMed  Google Scholar 

Freites-Martinez A, Santana N, Arias-Santiago S, Viera A (2021) Using the Common Terminology Criteria for Adverse Events (CTCAE - Version 5.0) to evaluate the severity of adverse events of anticancer therapies. Actas Dermosifiliogr (Engl Ed) 112:90–92

Article  CAS  PubMed  Google Scholar 

World Health Organization (2018) The use of the WHO-UMC system for standardised case causality assessment 2018. https://www.who.int/docs/default-source/medicines/pharmacovigilance/whocausality-assessment.pdf. Accessed 6 March 2023

Zannad F, Hsu BG, Maeda Y, Shin SK, Vishneva EM, Rensfeldt M, Eklund S, Zhao J (2020) Efficacy and safety of sodium zirconium cyclosilicate for hyperkalaemia: the randomized, placebo-controlled HARMONIZE-Global study. ESC Heart Fail 7:54–64

PubMed  PubMed Central  Google Scholar 

Yoo N, Song YB, Dubinsky I, Altshuler J (2023) Single dose of sodium zirconium cyclosilicate versus sodium polystyrene sulfonate in hospitalized patients with hyperkalemia. Ann Pharmacother 57:1044–1052

Article  CAS  PubMed  Google Scholar 

Spinowitz BS, Fishbane S, Pergola PE, Roger SD, Lerma EV, Butler J, von Haehling S, Adler SH, Zhao J, Singh B, Lavin PT, McCullough PA, Kosiborod M, Packham DK, ZS-005 Study Investigators (2019) Sodium zirconium cyclosilicate among individuals with hyperkalemia: a 12-month phase 3 study. Clin J Am Soc Nephrol 14:798–809

Article  CAS  PubMed  PubMed Central  Google Scholar 

Roger SD, Lavin PT, Lerma EV, McCullough PA, Butler J, Spinowitz BS, von Haehling S, Kosiborod M, Zhao J, Fishbane S, Packham DK (2021) Long-term safety and efficacy of sodium zirconium cyclosilicate for hyperkalaemia in patients with mild/moderate versus severe/end-stage chronic kidney disease: comparative results from an open-label, Phase 3 study. Nephrol Dial Transplant 36:137–150

Article  CAS  PubMed  Google Scholar 

Kashihara N, Yamasaki Y, Osonoi T, Harada H, Shibagaki Y, Zhao J, Kim H, Yajima T, Sarai N (2021) A phase 3 multicenter open-label maintenance study to investigate the long-term safety of sodium zirconium cyclosilicate in Japanese subjects with hyperkalemia. Clin Exp Nephrol 25:140–149

Article  CAS  PubMed  Google Scholar 

Avesani CM, Heimbürger O, Sallstrom T, Danielsson A, Rubin C, Irving GF, Lindholm B, Stenvinkel P (2023) #2538 healthy plant-based diet in chronic kidney disease through use of sodium zirconium cyclosilicate (helpful trial): laboratorial findings. Nephrol Dial Transplant 38:i1176–i1177

Article  Google Scholar 

Joshi S, Hashmi S, Shah S, Kalantar-Zadeh K (2020) Plant-based diets for prevention and management of chronic kidney disease. Curr Opin Nephrol Hypertens 29:16–21

Article  PubMed  Google Scholar 

Snauwaert E, Paglialonga F, Vande Walle J, Wan M, Desloovere A, Polderman N, Renken-Terhaerdt J, Shaw V, Shroff R (2023) The benefits of dietary fiber: the gastrointestinal tract and beyond. Pediatr Nephrol 38:2929–2938

Article  PubMed  Google Scholar 

Siirtola A, Virtanen SM, Ala-Houhala M, Koivisto AM, Solakivi T, Lehtimaki T, Holmberg C, Antikainen M, Salo MK (2008) Diet does not explain the high prevalence of dyslipidaemia in paediatric renal transplant recipients. Pediatr Nephrol 23:297–305

Article  PubMed  Google Scholar 

El Amouri A, Snauwaert E, Foulon A, Vande Moortel C, Van Dyck M, Van Hoeck K, Godefroid N, Glorieux G, Van Biesen W, Vande Walle J, Raes A, Eloot S (2021) Dietary fibre intake is associated with serum levels of uraemic toxins in children with chronic kidney disease. Toxins (Basel) 13:225

Article  PubMed  Google Scholar 

Clegg DJ, Headley SA, Germain MJ (2020) Impact of dietary potassium restrictions in CKD on clinical outcomes: benefits of a plant-based diet. Kidney Med 2:476–487

Article  PubMed  PubMed Central  Google Scholar 

Morales E, Cravedi P, Manrique J (2021) Management of chronic hyperkalemia in patients with chronic kidney disease: an old problem with news options. Front Med (Lausanne) 8:653634

Article  PubMed  Google Scholar 

Nagard M, Singh B, Boulton DW (2021) Effects of sodium zirconium cyclosilicate on sodium and potassium excretion in healthy adults: a Phase 1 study. Clin Kidney J 14:1924–1931

Article  CAS  PubMed  Google Scholar 

Spinowitz B, McCafferty K, Fishbane S, Fukagawa M, Guzman N, Ford M, Rastogi A, Bhandari S (2022) Dose effect analysis of sodium zirconium cyclosilicate in hemodialysis patients. Hemodial Int 26:274–277

Article  PubMed  Google Scholar 

Roger SD, Spinowitz BS, Lerma EV, Fishbane S, Ash SR, Martins JG, Quinn CM, Packham DK (2021) Sodium zirconium cyclosilicate increases serum bicarbonate concentrations among patients with hyperkalaemia: exploratory analyses from three randomized, multi-dose, placebo-controlled trials. Nephrol Dial Transplant 36:871–883

Article  CAS  PubMed  Google Scholar 

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