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

June 17, 2025 updated by: AstraZeneca

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2690

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
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  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
        • Research Site
      • Gotse Delchev, Bulgaria, 2900
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      • Haskovo, Bulgaria, 6300
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      • Pleven, Bulgaria, 5800
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      • Plovdiv, Bulgaria, 4000
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      • Razlog, Bulgaria, 2760
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      • Samokov, Bulgaria, 2000
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      • 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
        • Research Site
  • Canada
      • Quebec, Canada, G1R 2J6
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    • 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
        • Research Site
    • 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
        • Research Site
      • Changchun, China, 130021
        • Research Site
      • Changsha, China, 410013
        • Research Site
      • Changsha, China, 410004
        • Research Site
      • Changsha, China, 410008
        • Research Site
      • Changsha, China, 430033
        • Research Site
      • Changzhou, China, 213000
        • Research Site
      • Chengdu, China, 610000
        • Research Site
      • Chengdu, China, 610500
        • Research Site
      • Dongguan, China, 523009
        • Research Site
      • Foshan, China, 528000
        • Research Site
      • Fuzhou, China, 350001
        • Research Site
      • Guangzhou, China, 510000
        • Research Site
      • Guangzhou, China, 510080
        • Research Site
      • Guangzhou, China, 510630
        • Research Site
      • Guangzhou, China, 510800
        • Research Site
      • Guangzhou, China, 511400
        • Research Site
      • Guilin, China, 541000
        • Research Site
      • Guiyang, China, 550004
        • Research Site
      • Guiyang, China, 550002
        • Research Site
      • Haikou, China, 570311
        • Research Site
      • Hangzhou, China, 310014
        • Research Site
      • Hefei, China, 230601
        • Research Site
      • Hohhot, China, 10050
        • Research Site
      • Huai'an, China, 223300
        • Research Site
      • Jinan, China, 250031
        • Research Site
      • Jinhua, China, 322100
        • Research Site
      • Jiujiang, China, 332000
        • Research Site
      • 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
        • Research Site
      • Panjin, China, 124009
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      • Pingxiang, China, 337055
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      • Qingdao, China, 266011
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      • Shanghai, China, 201199
        • Research Site
      • Shanghai, China, 200240
        • Research Site
      • Shanghai, China, 201200
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      • Shengyang, China, 110004
        • Research Site
      • Shenzhen, China, 518020
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      • Siping, China, 136000
        • Research Site
      • 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
        • Research Site
      • WuHan, China, 430022
        • Research Site
      • Wuhan, China, 430010
        • Research Site
      • Wuhu, China, 241000
        • Research Site
      • Wuxi, China, 214023
        • Research Site
      • Xiamen, China, 361004
        • Research Site
      • Xianyang, China, 712000
        • Research Site
      • 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
        • Research Site
      • Havlickuv Brod, Czechia, 580 22
        • Research Site
      • Jilemnice, Czechia, 514 01
        • Research Site
      • Klatovy, Czechia, 339 01
        • Research Site
      • Liberec, Czechia, 460 63
        • Research Site
      • Nove Mesto na Morave, Czechia, 692 31
        • Research Site
      • Plzen, Czechia, 32300
        • Research Site
      • Praha 4, Czechia, 140 21
        • Research Site
      • Tabor, Czechia, 390 03
        • Research Site
      • Trebic, Czechia, 674 01
        • Research Site
  • Germany
      • Cloppenburg, Germany, 49661
        • Research Site
      • Düsseldorf, Germany, 40210
        • Research Site
      • Hannover, Germany, 30625
        • Research Site
      • Minden, Germany, 32429
        • Research Site
      • Potsdam, Germany, 14467
        • Research Site
      • Stuttgart, Germany, 70376
        • Research Site
      • Villingen-Schwenningen, Germany, 78052
        • Research Site
  • Hungary
      • Baja, Hungary, 6500
        • Research Site
      • Budapest, Hungary, 1083
        • Research Site
      • Kaposvár, Hungary, 7400
        • Research Site
      • Karcag, Hungary, 5300
        • Research Site
      • Kistarcsa, Hungary, 2143
        • Research Site
      • Miskolc, Hungary, 3526
        • Research Site
      • Nagykanizsa, Hungary, 8800
        • Research Site
      • 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
        • Research Site
      • 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
        • Research Site
      • Shiroishi-shi, Japan, 989-0231
        • Research Site
      • Tamana-shi, Japan, 865-0016
        • Research Site
      • Toride-shi, Japan, 302-0011
        • Research Site
      • Tsuchiura-shi, Japan, 300-0062
        • Research Site
      • Tsuchiura-shi, Japan, 300-0835
        • Research Site
      • Tsukuba-shi, Japan, 305-0861
        • Research Site
      • Ushiku-shi, Japan, 300-1296
        • Research Site
      • Yatomi-shi, Japan, 498-0006
        • Research Site
  • Malaysia
      • Batu Caves, Malaysia, 68100
        • Research Site
      • Ipoh, Malaysia, 30990
        • Research Site
      • Melaka, Malaysia, 75400
        • Research Site
      • 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
        • Research Site
      • Morelia, Mexico, 58260
        • Research Site
      • San Luis Potosí, Mexico, 78250
        • Research Site
      • Veracruz, Mexico, 91900
        • Research Site
      • 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
        • Research Site
      • Lima, Peru, 15036
        • Research Site
      • Lima, Peru, 15088
        • Research Site
      • Piura, Peru, 20001
        • Research Site
  • Poland
      • Gdańsk, Poland, 80-462
        • Research Site
      • Leżajsk, Poland, 37-300
        • Research Site
      • Lublin, Poland, 20-954
        • Research Site
      • Oleśnica, Poland, 56-400
        • Research Site
      • Olkusz, Poland, 32-300
        • Research Site
      • Pszczyna, Poland, 43-200
        • Research Site
      • Słupsk, Poland, 76-200
        • Research Site
      • Tczew, Poland, 83-110
        • Research Site
      • Wołomin, Poland, 05-200
        • Research Site
      • Wroclaw, Poland, 50-981
        • Research Site
      • Łódź, Poland, 90-153
        • Research Site
      • Łódź, Poland, 92-213
        • Research Site
      • Żory, Poland, 44-240
        • Research Site
      • 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
        • Research Site
      • Lucenec, Slovakia, 984 01
        • Research Site
      • Puchov, Slovakia, 2001
        • Research Site
      • Žilina, Slovakia, 010 01
        • Research Site
  • Spain
      • Alcalá de Henares, Spain, 28805
        • Research Site
      • Barcelona, Spain, 08025
        • Research Site
      • Cordoba, Spain, 14004
        • Research Site
      • Madrid, Spain, 28031
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      • Madrid, Spain, 28006
        • Research Site
      • Madrid, Spain, 28007
        • Research Site
      • Pamplona, Spain, 31008
        • Research Site
      • Valencia, Spain, 46017
        • Research Site
  • Taiwan
      • Kaohsiung, Taiwan
        • Research Site
      • Keelung, Taiwan, 20448
        • Research Site
      • Linkou, Taiwan, 244
        • Research Site
      • New Taipei, Taiwan, 220
        • Research Site
      • New Taipei, Taiwan, 23561
        • Research Site
      • Taichung, Taiwan, 40705
        • Research Site
      • Taipei, Taiwan, 100
        • Research Site
      • Taipei City, Taiwan, 114
        • Research Site
      • Taipei City, Taiwan, 110
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10330
        • Research Site
      • Chiang Mai, Thailand, 50200
        • Research Site
      • Hat Yai, Thailand, 90110
        • Research Site
      • Ratchathewi, Thailand, 10400
        • Research Site
  • Turkey
      • Adapazarı, Turkey, 54100
        • Research Site
      • Ankara, Turkey, 06800
        • Research Site
      • Gaziantep, Turkey, 27310
        • Research Site
      • Kahramanmaras, Turkey, 46100
        • Research Site
      • Kayseri, Turkey, 38039
        • Research Site
      • Kocaeli, Turkey, 41380
        • Research Site
  • Ukraine
      • Chernivtsі, Ukraine, 58001
        • Research Site
      • Dnipro, Ukraine, 49005
        • Research Site
      • Ivano-Frankivsk, Ukraine, 78018
        • Research Site
      • Kyiv, Ukraine, 02125
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      • Kyiv, Ukraine, 04107
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      • Kyiv, Ukraine, 03680
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      • Kyiv, Ukraine, 01004
        • Research Site
      • Odesa, Ukraine, 65074
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      • Ternopil, Ukraine, 46001
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      • Uzhhorod, Ukraine, 88018
        • Research Site
      • Vinnytsia, Ukraine, 21018
        • Research Site
      • Zaporizhzhia, Ukraine, 69001
        • Research Site
      • Zaporizhzhia, Ukraine, 69600
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  • United Kingdom
      • Bristol, United Kingdom, BS105NB
        • Research Site
      • Leicester, United Kingdom, Le5 4PW
        • Research Site
      • 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
        • Research Site
      • Salford, United Kingdom, M6 8HD
        • Research Site
      • Swansea, United Kingdom, SN6 6NL
        • Research Site
      • 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
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55435
        • Research Site
    • Mississippi
      • Brookhaven, Mississippi, United States, 39601
        • Research Site
      • Columbus, Mississippi, United States, 39705
        • Research Site
      • Tupelo, Mississippi, United States, 38801
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Research Site
      • Saint Louis, Missouri, United States, 63110
        • Research Site
      • Saint Louis, Missouri, United States, 63117
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Research Site
      • Las Vegas, Nevada, United States, 89128
        • Research Site
    • New Jersey
      • Jersey City, New Jersey, United States, 07305
        • Research Site
    • 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
        • Research Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Research Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Research Site
    • South Carolina
      • Spartanburg, South Carolina, United States, 29306
        • Research Site
    • Texas
      • Austin, Texas, United States, 78758
        • Research Site
      • Austin, Texas, United States, 78751
        • Research Site
      • Conroe, Texas, United States, 77384
        • Research Site
      • 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
        • Research Site
    • Utah
      • Saint George, Utah, United States, 84770
        • Research Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Research Site
      • Virginia Beach, Virginia, United States, 23454
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Research Site
  • Vietnam
      • Bien Hoa, Vietnam, 810000
        • Research Site
      • Da Nang, Vietnam, 55000
        • Research Site
      • Hanoi, Vietnam, 100000
        • Research Site
      • Hanoi, Vietnam, 10000
        • Research Site
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of the Composite of Cardiac Event Outcomes
Time Frame: From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)
Incidence of the composite endpoint of SCD, all stroke, or hospitalization/intervention/emergency department (ED) visit due to arrhythmias is analyzed based on Cox regression model with treatment and region as covariates. Patients with no events are censored at final clinical assessment, death, or disposition event.
From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Normokalemia at 12 Months Post-randomization
Time Frame: Randomization to 12-Month Visit
Logistic regression analysis of whether a subject is Normokalemic (S-K of 4.0 - 5.5 mmol/L ) after the LIDI at the 12-month visit.
Randomization to 12-Month Visit
Incidence of the Composite of Arrhythmia Related Events
Time Frame: From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)
Incidence of the composite endpoint of hospitalization, intervention, emergency department (ED) visit due to arrhythmias is analyzed based on Cox regression model with treatment and region as covariates. Patients with no events are censored at final clinical assessment, death, or disposition event.
From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Adverse Events (AEs)/ Serious Adverse Events (SAEs)
Time Frame: From randomization/ screening visit through study completion during study visits every 3 months, over an average of 3 years
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)
Time Frame: From randomization visit through study completion during study visits every 3 months, over an average of 3 years
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
Time Frame: From randomization visit through study completion during study visits every 3 months, over an average of 3 years
From randomization visit through study completion during study visits every 3 months, over an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Steven Fishbane, Professor, MD, North Shore University Hospital, 300 Community Drive, Manhasset, NY 11030

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 7, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 7, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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