Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)

An International, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)

The purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC) on arrhythmia-related cardiovascular outcomes in participants on chronic hemodialysis with recurrent hyperkalemia.

Study Overview

• Status: Terminated
• Conditions: Hyperkalemia
• Intervention / Treatment: Drug: Sodium Zirconium Cyclosilicate (SZC); Drug: SZC Placebo

Detailed Description

This is an international, multicenter, event-driven, randomized, double-blind, parallel group, placebo-controlled study, evaluating the utility of SZC versus placebo to reduce the incidence of sudden cardiac death (SCD), stroke, and arrhythmia-related hospitalizations, interventions, and emergency department (ED) visits in participants on chronic hemodialysis with recurrent hyperkalemia.

• Study Type: Interventional
• Enrollment (Actual): 2698
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Córdoba, Argentina, X5016LIG
    • Research Site
  • Junín, Argentina, 6000
    • Research Site
  • Mar del Plata, Argentina, B7600DBZ
    • Research Site
  • Pergamino, Argentina, B2700LDK
    • Research Site
  • San Luis, Argentina, 5700
    • Research Site
  • San Luis, Argentina, D5700CTA
    • Research Site
  • Santa Rosa, Argentina, L6300
    • Research Site
  • Sarandi, Argentina, B1872EEC
    • Research Site
• Austria
  • Graz, Austria, 8036
    • Research Site
  • Innsbruck, Austria, 6020
    • Research Site
• Brazil
  • Brasilia, Brazil, 70390-700
    • Research Site
  • Curitiba, Brazil, 80230-130
    • Research Site
  • Curitiba, Brazil, 80440-020
    • Research Site
  • Joinville, Brazil, 89227-680
    • Research Site
  • Maringá, Brazil, 87060-040
    • Research Site
  • Porto Alegre, Brazil, 90020-090
    • Research Site
  • Porto Alegre, Brazil, 90160-093
    • Research Site
  • Recife, Brazil, 50720-635
    • Research Site
  • Ribeirao Preto, Brazil, 14025-170
    • Research Site
  • Rio De Janeiro, Brazil, 20551-030
    • Research Site
  • Sao Paulo, Brazil, 05403-9000
    • Research Site
  • São Paulo, Brazil, 04038-031
    • Research Site
  • São Paulo, Brazil, 05024-040
    • Research Site
• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • Research Site
  • Gotse Delchev, Bulgaria, 2900
    • Research Site
  • Haskovo, Bulgaria, 6300
    • Research Site
  • Pleven, Bulgaria, 5800
    • Research Site
  • Plovdiv, Bulgaria, 4000
    • Research Site
  • Razlog, Bulgaria, 2760
    • Research Site
  • Samokov, Bulgaria, 2000
    • Research Site
  • Sandanski, Bulgaria, 2800
    • Research Site
  • Silistra, Bulgaria, 7500
    • Research Site
  • Smolyan, Bulgaria, 3700
    • Research Site
  • Sofia, Bulgaria, 1606
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  • Stara Zagora, Bulgaria, 6000
    • Research Site
  • Varna, Bulgaria, 9010
    • Research Site
  • Yambol, Bulgaria, 8600
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• Canada
  • Quebec, Canada, G1R 2J6
    • Research Site
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Research Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Research Site
    • Sydney, Nova Scotia, Canada, B1P 1P3
      • Research Site
  • Ontario
    • Oshawa, Ontario, Canada, L1G 2B9
      • Research Site
    • Toronto, Ontario, Canada, M3M 0B2
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  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Research Site
    • Montreal, Quebec, Canada, H4J 1C5
      • Research Site
    • Montreal, Quebec, Canada, H1T 2M4
      • Research Site
    • Montreal, Quebec, Canada, H2T 3B3
      • Research Site
    • Montreal, Quebec, Canada, H3T 1E4
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• China
  • Beijing, China, 100034
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  • Beijing, China, 100029
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  • Beijing, China, 100191
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  • Changchun, China, 130021
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  • Changsha, China, 410013
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  • Changsha, China, 410004
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  • Changsha, China, 410008
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  • Changsha, China, 430033
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  • Changzhou, China, 213000
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  • Chengdu, China, 610000
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  • Chengdu, China, 610500
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  • Dongguan, China, 523009
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  • Foshan, China, 528000
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  • Fuzhou, China, 350001
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  • Guangzhou, China, 510000
    • Research Site
  • Guangzhou, China, 510080
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  • Guangzhou, China, 510630
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  • Guangzhou, China, 510800
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  • Guangzhou, China, 511400
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  • Guilin, China, 541000
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  • Guiyang, China, 550004
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  • Guiyang, China, 550002
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  • Haikou, China, 570311
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  • Hangzhou, China, 310014
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  • Hefei, China, 230601
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  • Hohhot, China, 10050
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  • Huai'an, China, 223300
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  • Jinan, China, 250031
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  • Jinhua, China, 322100
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  • Jiujiang, China, 332000
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  • Kunming, China, 650032
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  • Lanzhou, China, 730030
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  • Lanzhou, China, 730000
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  • Nanchang, China, 330006
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  • Nanjing, China, 210009
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  • Nanjing, China, 210029
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  • Nanyang, China, 473000
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  • Ningbo, China, 315010
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  • Panjin, China, 124009
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  • Pingxiang, China, 337055
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  • Qingdao, China, 266011
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  • Shanghai, China, 201199
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  • Shanghai, China, 200240
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  • Shanghai, China, 201200
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  • Shengyang, China, 110004
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  • Shenzhen, China, 518020
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  • Siping, China, 136000
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  • Taian, China, 271099
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  • Taiyuan, China, 030012
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  • Tianjin, China, 300121
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  • Tianjin, China, 300192
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  • Urumqi, China, CN-830004
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  • Wenzhou, China, 325027
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  • WuHan, China, 430022
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  • Wuhan, China, 430010
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  • Wuhu, China, 241000
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  • Wuxi, China, 214023
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  • Xiamen, China, 361004
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  • Xianyang, China, 712000
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  • Yibin, China, 644000
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  • Yinchuan, China, 750004
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  • Zhengzhou, China, 450052
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  • Zhuzhou, China, 412007
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• Czechia
  • Ceske Budejovice, Czechia, 370 01
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  • Havlickuv Brod, Czechia, 580 22
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  • Jilemnice, Czechia, 514 01
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  • Klatovy, Czechia, 339 01
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  • Liberec, Czechia, 460 63
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  • Nove Mesto na Morave, Czechia, 692 31
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  • Plzen, Czechia, 32300
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  • Praha 4, Czechia, 140 21
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  • Tabor, Czechia, 390 03
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  • Trebic, Czechia, 674 01
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• Germany
  • Cloppenburg, Germany, 49661
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  • Düsseldorf, Germany, 40210
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  • Hannover, Germany, 30625
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  • Minden, Germany, 32429
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  • Potsdam, Germany, 14467
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  • Stuttgart, Germany, 70376
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  • Villingen-Schwenningen, Germany, 78052
    • Research Site
• Hungary
  • Baja, Hungary, 6500
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  • Budapest, Hungary, 1083
    • Research Site
  • Kaposvár, Hungary, 7400
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  • Karcag, Hungary, 5300
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  • Kistarcsa, Hungary, 2143
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  • Miskolc, Hungary, 3526
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  • Nagykanizsa, Hungary, 8800
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  • Szombathely, Hungary, 9700
    • Research Site
• India
  • Ahmedabad, India, 380054
    • Research Site
  • Chennai, India, 600037
    • Research Site
  • Dhanvantari Nagar, India, 605006
    • Research Site
  • Nadiad, India, 387001
    • Research Site
  • Pune, India, 411013
    • Research Site
• Italy
  • Bassano del Grappa, Italy, 36061
    • Research Site
  • Bergamo, Italy, 24127
    • Research Site
  • Bologna, Italy, 40138
    • Research Site
  • Caserta, Italy, 81100
    • Research Site
  • Milano, Italy, 20132
    • Research Site
  • Monza, Italy, 20052
    • Research Site
  • Parma, Italy, 43100
    • Research Site
  • Pavia, Italy, 27100
    • Research Site
  • Pesaro, Italy, 61121
    • Research Site
  • Roma, Italy, 00168
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  • San Giovanni Rotondo, Italy, 71013
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  • Verona, Italy, 37124
    • Research Site
• Japan
  • Fujisawa-shi, Japan, 251-0041
    • Research Site
  • Fukuoka-shi, Japan, 810-0004
    • Research Site
  • Hamamatsu-shi, Japan, 434-0018
    • Research Site
  • Kawasaki-shi, Japan, 210-0852
    • Research Site
  • Kumagaya-shi, Japan, 360-0831
    • Research Site
  • Kumamoto-shi, Japan, 861-8520
    • Research Site
  • Kyoto-shi, Japan, 600-8216
    • Research Site
  • Moriya-shi, Japan, 3020118
    • Research Site
  • Nagano-shi, Japan, 380-0904
    • Research Site
  • Nagasaki-shi, Japan, 852-8053
    • Research Site
  • Nakagami-gun, Japan, 901-2393
    • Research Site
  • Okinawa-shi, Japan, 904-2143
    • Research Site
  • Omihachiman-shi, Japan, 523-0082
    • Research Site
  • Sashima-gun, Japan, 306-0433
    • Research Site
  • Setagaya-ku, Japan, 158-0094
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  • Shiroishi-shi, Japan, 989-0231
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  • Tamana-shi, Japan, 865-0016
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  • Toride-shi, Japan, 302-0011
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  • Tsuchiura-shi, Japan, 300-0062
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  • Tsuchiura-shi, Japan, 300-0835
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  • Tsukuba-shi, Japan, 305-0861
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  • Ushiku-shi, Japan, 300-1296
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  • Yatomi-shi, Japan, 498-0006
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• Malaysia
  • Batu Caves, Malaysia, 68100
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  • Ipoh, Malaysia, 30990
    • Research Site
  • Melaka, Malaysia, 75400
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  • Seri Manjung, Malaysia, 32040
    • Research Site
• Mexico
  • Chihuahua, Mexico, 31203
    • Research Site
  • Culiacán, Mexico, 80230
    • Research Site
  • D.F, Mexico, 14000
    • Research Site
  • Mazatlán, Mexico, 82000
    • Research Site
  • Mexico City, Mexico, 0 3100
    • Research Site
  • Monterrey, Mexico, 64610
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  • Morelia, Mexico, 58260
    • Research Site
  • San Luis Potosí, Mexico, 78250
    • Research Site
  • Veracruz, Mexico, 91910
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  • Xalapa, Mexico, 91020
    • Research Site
  • Zapopan, Mexico, 45138
    • Research Site
• Peru
  • Cusco, Peru, CUSCO 01
    • Research Site
  • Lima, Peru, 14
    • Research Site
  • Lima, Peru, LIMA 01
    • Research Site
  • Lima, Peru, 15046
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  • Lima, Peru, 15036
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  • Lima, Peru, 15088
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  • Piura, Peru, 20001
    • Research Site
• Poland
  • Gdańsk, Poland, 80-462
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  • Leżajsk, Poland, 37-300
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  • Lublin, Poland, 20-954
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  • Oleśnica, Poland, 56-400
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  • Olkusz, Poland, 32-300
    • Research Site
  • Pszczyna, Poland, 43-200
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  • Słupsk, Poland, 76-200
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  • Tczew, Poland, 83-110
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  • Wołomin, Poland, 05-200
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  • Wroclaw, Poland, 50-981
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  • Łódź, Poland, 90-153
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  • Łódź, Poland, 92-213
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  • Żory, Poland, 44-240
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  • Żyrardów, Poland, 96-300
    • Research Site
• Russian Federation
  • Kemerovo, Russian Federation, 650000
    • Research Site
  • Mytischi, Russian Federation, 141009
    • Research Site
  • Novosibirsk, Russian Federation, 630087
    • Research Site
  • Omsk, Russian Federation, 644112
    • Research Site
  • Penza, Russian Federation, 440034
    • Research Site
  • Saint Petersburg, Russian Federation, 191167
    • Research Site
  • Saint-Petersburg, Russian Federation, 190103
    • Research Site
  • Yaroslavl, Russian Federation, 150062
    • Research Site
• Slovakia
  • Bratislava, Slovakia, 85107
    • Research Site
  • Komárno, Slovakia, 945 75
    • Research Site
  • Kosice, Slovakia, 04011
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  • Lucenec, Slovakia, 984 01
    • Research Site
  • Puchov, Slovakia, 2001
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  • Žilina, Slovakia, 010 01
    • Research Site
• Spain
  • Alcala de Henares, Spain, 28805
    • Research Site
  • Barcelona, Spain, 08025
    • Research Site
  • Cordoba, Spain, 14004
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  • Madrid, Spain, 28031
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  • Madrid, Spain, 28006
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  • Madrid, Spain, 28007
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  • Pamplona, Spain, 31008
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  • Valencia, Spain, 46017
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• Taiwan
  • Kaohsiung, Taiwan
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  • Keelung, Taiwan, 20448
    • Research Site
  • Linkou, Taiwan, 244
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  • New Taipei, Taiwan, 220
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  • New Taipei, Taiwan, 23561
    • Research Site
  • Taichung, Taiwan, 40705
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  • Taipei, Taiwan, 100
    • Research Site
  • Taipei City, Taiwan, 114
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  • Taipei City, Taiwan, 110
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• Thailand
  • Bangkok, Thailand, 10330
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  • Chiang Mai, Thailand, 50200
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  • Hat Yai, Thailand, 90110
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  • Ratchathewi, Thailand, 10400
    • Research Site
• Turkey
  • Adapazarı, Turkey, 54100
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  • Ankara, Turkey, 06800
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  • Gaziantep, Turkey, 27310
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  • Kahramanmaras, Turkey, 46100
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  • Kayseri, Turkey, 38039
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  • Kocaeli, Turkey, 41380
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• Ukraine
  • Chernivtsі, Ukraine, 58001
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  • Dnipro, Ukraine, 49005
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  • Ivano-Frankivsk, Ukraine, 78018
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  • Kyiv, Ukraine, 02125
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  • Kyiv, Ukraine, 04107
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  • Kyiv, Ukraine, 03680
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  • Kyiv, Ukraine, 01004
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  • Odesa, Ukraine, 65074
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  • Ternopil, Ukraine, 46001
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  • Uzhhorod, Ukraine, 88018
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  • Vinnytsia, Ukraine, 21018
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  • Zaporizhzhia, Ukraine, 69001
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  • Zaporizhzhia, Ukraine, 69600
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• United Kingdom
  • Bristol, United Kingdom, BS105NB
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  • Leicester, United Kingdom, LE5 4PW
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  • Liverpool, United Kingdom, L9 7AL
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  • London, United Kingdom, E1 1BB
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  • London, United Kingdom, SE1 2PR
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  • Preston, United Kingdom, PR2 9HT
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  • Salford, United Kingdom, M6 8HD
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  • Swansea, United Kingdom, SN6 6NL
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  • Wolverhampton, United Kingdom, WV10 OQP
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• United States
  • Alabama
    • Huntsville, Alabama, United States, 35805
      • Research Site
  • Arizona
    • Mesa, Arizona, United States, 85210
      • Research Site
  • California
    • Bakersfield, California, United States, 93309
      • Research Site
    • Glendale, California, United States, 91206
      • Research Site
    • Granada Hills, California, United States, 91344
      • Research Site
    • Lynwood, California, United States, 90262
      • Research Site
    • San Diego, California, United States, 92111
      • Research Site
    • Vacaville, California, United States, 95687
      • Research Site
    • Victorville, California, United States, 92394
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  • Colorado
    • Denver, Colorado, United States, 80210
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  • Connecticut
    • Bloomfield, Connecticut, United States, 06002
      • Research Site
    • Middlebury, Connecticut, United States, 06762
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  • Delaware
    • Newark, Delaware, United States, 19713
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  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Research Site
    • Tampa, Florida, United States, 33603
      • Research Site
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Research Site
    • Lawrenceville, Georgia, United States, 30046
      • Research Site
    • Statesboro, Georgia, United States, 30458
      • Research Site
  • Idaho
    • Nampa, Idaho, United States, 83687
      • Research Site
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Research Site
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70815
      • Research Site
  • Michigan
    • Detroit, Michigan, United States, 48202-2689
      • Research Site
    • Kalamazoo, Michigan, United States, 49007
      • Research Site
    • Roseville, Michigan, United States, 48066
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  • Minnesota
    • Minneapolis, Minnesota, United States, 55435
      • Research Site
  • Mississippi
    • Brookhaven, Mississippi, United States, 39601
      • Research Site
    • Columbus, Mississippi, United States, 39705
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    • Tupelo, Mississippi, United States, 38801
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  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Research Site
    • Saint Louis, Missouri, United States, 63110
      • Research Site
    • Saint Louis, Missouri, United States, 63117
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  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Research Site
    • Las Vegas, Nevada, United States, 89128
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  • New Jersey
    • Jersey City, New Jersey, United States, 07305
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  • New York
    • Bronx, New York, United States, 10461
      • Research Site
    • Manhasset, New York, United States, 11030
      • Research Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28208
      • Research Site
    • New Bern, North Carolina, United States, 28562
      • Research Site
    • Winston-Salem, North Carolina, United States, 27103
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  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
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  • Rhode Island
    • Providence, Rhode Island, United States, 02903
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  • South Carolina
    • Spartanburg, South Carolina, United States, 29306
      • Research Site
  • Texas
    • Austin, Texas, United States, 78758
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    • Austin, Texas, United States, 78751
      • Research Site
    • Conroe, Texas, United States, 77384
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    • El Paso, Texas, United States, 79935
      • Research Site
    • El Paso, Texas, United States, 79925
      • Research Site
    • Greenville, Texas, United States, 75402
      • Research Site
    • Houston, Texas, United States, 77090
      • Research Site
    • Houston, Texas, United States, 77054
      • Research Site
    • San Antonio, Texas, United States, 78229
      • Research Site
    • San Antonio, Texas, United States, 78251
      • Research Site
    • San Antonio, Texas, United States, 78258
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  • Utah
    • Saint George, Utah, United States, 84770
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  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Research Site
    • Virginia Beach, Virginia, United States, 23454
      • Research Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
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• Vietnam
  • Bien Hoa, Vietnam, 810000
    • Research Site
  • Da Nang, Vietnam, 55000
    • Research Site
  • Hanoi, Vietnam, 100000
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  • Hanoi, Vietnam, 10000
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  • Ho Chi Minh, Vietnam, 700000
    • Research Site
  • Ho Chi Minh, Vietnam, 10000
    • Research Site
  • Ho Chi Minh City, Vietnam, 70000
    • Research Site
  • Hue, Vietnam, 530000
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
2. Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses
3. Must be ≥ 18 years of age, at the time of signing the ICF.
4. Receiving hemodialysis (or hemodiafiltration) 3 times a week for treatment of ESRD for ≥ 4 months before enrollment
5. Must have hemodialysis access consisting of an arteriovenous fistula, arteriovenous graft, or tunneled (permanent) catheter which is expected to remain in place for the entire duration of the study
6. At least 2 out of 3 pre-dialysis S K ≥ 5.5 mmol/L after the LIDI during screening
7. Negative pregnancy test for female participants of childbearing potential
8. Female participants must be 1 year postmenopausal, surgically sterile, or using one highly effective form of birth control (defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly). They should have been stable on their chosen method of birth control for a minimum of 3 months before entering the study and willing to remain on the birth control until 12 weeks after the last dose

Exclusion Criteria:

1. Pseudohyperkalemia secondary to hemolyzed blood specimen (this situation is not considered screening failure, sampling or full screening can be postponed to a later time as applicable)
2. Presence of cardiac arrhythmias or conduction defects that require immediate treatment
3. Participants who have a pacemaker or implantable cardiac defibrillator
4. Any medical condition, including active, clinically significant infection or liver disease, that in the opinion of the investigator or sponsor may pose a safety risk to a participant in this study, confound safety or efficacy assessment and jeopardize the quality of the data, or interfere with study participation, or any other restrictions or contraindications in the local prescribing information for SZC
5. History of QT prolongation associated with other medications that required discontinuation of that medication
6. Congenital long QT syndrome
7. QTcF > 550 msec
8. Atrial fibrillation requiring immediate/urgent intervention at screening or randomizations
9. Treated with sodium polystyrene sulfonate (SPS, Kayexalate, Resonium), calcium polystyrene sulfonate (CPS Resonium Calcium), patiromer (Veltassa), or SZC (Lokelma) within 7 days before screening or anticipated requiring chronic use of any of these agents during the study. If participant requires rescue therapy (potassium binder or dialysate S-K change during screening period), the participant will be screen failed
10. Participation in another clinical study with an investigational product, device, or non-standard hemodialysis procedure administered within one month before screening
11. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
12. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements
13. Previous randomization in the present study
14. Females who are pregnant (confirmed with positive pregnancy test or a uterine ultrasound if pregnancy test result is questionable), breastfeeding, or planning to become pregnant during the study
15. Known hypersensitivity or previous anaphylaxis to SZC or to components thereof
16. Scheduled date for living donor kidney transplant
17. Sustained Ventricular Tachycardia > 30 seconds requiring assessment / intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: SZC Placebo; Powder for oral suspension in a sachet. A dose is titrated in 5 g increments during a period of 4 weeks from 5 g up to 15 g qd on non-dialysis days. Afterward, the dose is adjusted monthly (or more frequent based on clinical judgment) depending on the current potassium value as measured after the LIDI.
Experimental: Sodium Zirconium Cyclosilicate	Drug: Sodium Zirconium Cyclosilicate (SZC); Powder for oral suspension in a sachet. A dose is titrated in 5 g increments during a period of 4 weeks from 5 g up to 15 g qd on non-dialysis days. Afterward, the dose is adjusted monthly (or more frequent based on clinical judgment) depending on the current potassium value as measured after the long interdialytic interval (LIDI).; Other Names: Lokelma TM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to first occurrence of SCD, stroke, or hospitalization/intervention/ED visit due to arrhythmias (atrial fibrillation [AF], bradycardia, asystole, ventricular tachyarrhythmia [VF, VT, etc.])	From randomization visit through study completion during study visits every 3 months, over an average of 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
S-K of 4.0-5.5 mmol/L (yes/no) after the long interdialytic interval (LIDI) at the 12 month visit	Evaluated at 12 months after randomization
S-K > 6.5 mmol/L (yes/no) after the LIDI at the 12 month visit	Evaluated at 12 months after randomization
Time to first occurrence of hospitalization/intervention/ED visit due to arrhythmias (AF, bradycardia, asystole, Ventricular tachyarrhythmia [VF, VT etc.])	From randomization visit through study completion during study visits every 3 months, over an average of 3 years
Number of hospitalizations/interventions/ED visits due to arrhythmias (AF, bradycardia, asystole, Ventricular tachyarrhythmia [VF, VT etc.])	From randomization visit through study completion during study visits every 3 months, over an average of 3 years
Time to first instance of rescue therapy use for hyperkalemia	From randomization visit through study completion during study visits every 3 months, over an average of 3 years
Time to SCD	From randomization visit through study completion during study visits every 3 months, over an average of 3 years
Time to first occurrence of stroke	From randomization visit through study completion during study visits every 3 months, over an average of 3 years
Time to cardiovascular (CV) death	From randomization visit through study completion during study visits every 3 months, over an average of 3 years
Time to death of any cause	From randomization visit through study completion during study visits every 3 months, over an average of 3 years

Other Outcome Measures

Outcome Measure	Time Frame
Adverse Events (AEs)/ Serious Adverse Events (SAEs)	From randomization/ screening visit through study completion during study visits every 3 months, over an average of 3 years
Events of pre-dialysis hypokalemia (S-K < 3.0 mmol/L)	From randomization visit through study completion during study visits every 3 months, over an average of 3 years
Change in interdialytic weight gain (kg) as compared to baseline	From randomization visit through study completion during study visits every 3 months, over an average of 3 years

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Steven Fishbane, Professor, MD, North Shore University Hospital, 300 Community Drive, Manhasset, NY 11030

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Actual): March 7, 2024
• Study Completion (Actual): March 7, 2024

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Hemodialysis; Hyperkalemia; Ventricular Tachycardia; Cardiovascular Events
• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyperkalemia
• Other Study ID Numbers: D9487C00001; 2020-005561-14 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No