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

PHASE3TerminatedINTERVENTIONAL
Enrollment

2,690

Participants

Timeline

Start Date

April 30, 2021

Primary Completion Date

March 7, 2024

Study Completion Date

March 7, 2024

Conditions
Hyperkalemia
Interventions
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).

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.

Trial Locations (340)

14

Research Site, Lima

100

Research Site, Taipei

110

Research Site, Taipei

114

Research Site, Taipei

220

Research Site, New Taipei City

244

Research Site, Linkou District

1083

Research Site, Budapest

1606

Research Site, Sofia

2000

Research Site, Samokov

2001

Research Site, Púchov

2143

Research Site, Kistarcsa

2700

Research Site, Blagoevgrad

2760

Research Site, Razlog

2800

Research Site, Sandanski

2900

Research Site, Gotse Delchev

3526

Research Site, Miskolc

3700

Research Site, Smolyan

4000

Research Site, Plovdiv

5300

Research Site, Karcag

5700

Research Site, San Luis

5800

Research Site, Pleven

6000

Research Site, Junín

Research Site, Stara Zagora

6020

Research Site, Innsbruck

6300

Research Site, Haskovo

6500

Research Site, Baja

7400

Research Site, Kaposvár

7500

Research Site, Silistra

8036

Research Site, Graz

8600

Research Site, Yambol

8800

Research Site, Nagykanizsa

9010

Research Site, Varna

9700

Research Site, Szombathely

10000

Research Site, Hanoi

Research Site, Ho Chi Minh City

10050

Research Site, Hohhot

10330

Research Site, Bangkok

10400

Research Site, Ratchathewi

10461

Research Site, The Bronx

11030

Research Site, Manhasset

14000

Research Site, D.F

14004

Research Site, Córdoba

14467

Research Site, Potsdam

15036

Research Site, Lima

15046

Research Site, Lima

15088

Research Site, Lima

18017

Research Site, Bethlehem

19713

Research Site, Newark

20001

Research Site, Piura

20052

Research Site, Monza

20132

Research Site, Milan

20448

Research Site, Keelung

21018

Research Site, Vinnytsia

23454

Research Site, Virginia Beach

23502

Research Site, Norfolk

23561

Research Site, New Taipei City

24127

Research Site, Bergamo

27100

Research Site, Pavia

27103

Research Site, Winston-Salem

27310

Research Site, Gaziantep

28006

Research Site, Madrid

28007

Research Site, Madrid

28031

Research Site, Madrid

28208

Research Site, Charlotte

28562

Research Site, New Bern

28805

Research Site, Alcalá de Henares

29306

Research Site, Spartanburg

30046

Research Site, Lawrenceville

30458

Research Site, Statesboro

30625

Research Site, Hanover

30990

Research Site, Ipoh

31008

Research Site, Pamplona

31203

Research Site, Chihuahua City

31904

Research Site, Columbus

32040

Research Site, Seri Manjung

32300

Research Site, Pilsen

32429

Research Site, Minden

33308

Research Site, Fort Lauderdale

33603

Research Site, Tampa

35805

Research Site, Huntsville

36061

Research Site, Bassano del Grappa

37124

Research Site, Verona

38039

Research Site, Kayseri

38801

Research Site, Tupelo

39601

Research Site, Brookhaven

39705

Research Site, Columbus

40138

Research Site, Bologna

40210

Research Site, Düsseldorf

40705

Research Site, Taichung

41380

Research Site, Kocaeli

43100

Research Site, Parma

45138

Research Site, Zapopan

46001

Research Site, Ternopil

46017

Research Site, Valencia

46100

Research Site, Kahramanmaraş

48066

Research Site, Roseville

49005

Research Site, Dnipro

49007

Research Site, Kalamazoo

49661

Research Site, Cloppenburg

50200

Research Site, Chiang Mai

52242

Research Site, Iowa City

53226

Research Site, Milwaukee

54100

Research Site, Adapazarı

55000

Research Site, Da Nang

55435

Research Site, Minneapolis

58001

Research Site, Chernivtsі

58260

Research Site, Morelia

61121

Research Site, Pesaro

63110

Research Site, St Louis

63117

Research Site, St Louis

64111

Research Site, Kansas City

64610

Research Site, Monterrey

65074

Research Site, Odesa

68100

Research Site, Batu Caves

69001

Research Site, Zaporizhzhia

69600

Research Site, Zaporizhzhia

70000

Research Site, Ho Chi Minh City

70376

Research Site, Stuttgart

70815

Research Site, Baton Rouge

71013

Research Site, San Giovanni Rotondo

75400

Research Site, Malacca

75402

Research Site, Greenville

77054

Research Site, Houston

77090

Research Site, Houston

77384

Research Site, Conroe

78018

Research Site, Ivano-Frankivsk

78052

Research Site, Villingen-Schwenningen

78229

Research Site, San Antonio

78250

Research Site, San Luis Potosí City

78251

Research Site, San Antonio

78258

Research Site, San Antonio

78751

Research Site, Austin

78758

Research Site, Austin

79925

Research Site, El Paso

79935

Research Site, El Paso

80210

Research Site, Denver

80230

Research Site, Culiacán

81100

Research Site, Caserta

82000

Research Site, Mazatlán

83687

Research Site, Nampa

84770

Research Site, St. George

85107

Research Site, Bratislava

85210

Research Site, Mesa

88018

Research Site, Uzhhorod

89106

Research Site, Las Vegas

89128

Research Site, Las Vegas

90110

Research Site, Hat Yai

90262

Research Site, Lynwood

91020

Research Site, Xalapa

91206

Research Site, Glendale

91344

Research Site, Granada Hills

91900

Research Site, Veracruz

92111

Research Site, San Diego

92394

Research Site, Victorville

93309

Research Site, Bakersfield

95687

Research Site, Vacaville

100000

Research Site, Hanoi

100029

Research Site, Beijing

100034

Research Site, Beijing

100191

Research Site, Beijing

110004

Research Site, Shengyang

124009

Research Site, Panjin

130021

Research Site, Changchun

136000

Research Site, Siping

141009

Research Site, Mytischi

150062

Research Site, Yaroslavl

190103

Research Site, Saint Petersburg

191167

Research Site, Saint Petersburg

200240

Research Site, Shanghai

201199

Research Site, Shanghai

201200

Research Site, Shanghai

210009

Research Site, Nanjing

210029

Research Site, Nanjing

213000

Research Site, Changzhou

214023

Research Site, Wuxi

223300

Research Site, Huai'an

230601

Research Site, Hefei

241000

Research Site, Wuhu

250031

Research Site, Jinan

266011

Research Site, Qingdao

271099

Research Site, Taian

300121

Research Site, Tianjin

300192

Research Site, Tianjin

310014

Research Site, Hangzhou

315010

Research Site, Ningbo

322100

Research Site, Jinhua

325027

Research Site, Wenzhou

330006

Research Site, Nanchang

332000

Research Site, Jiujiang

337055

Research Site, Pingxiang

350001

Research Site, Fuzhou

361004

Research Site, Xiamen

380054

Research Site, Ahmedabad

387001

Research Site, Nadiād

410004

Research Site, Changsha

410008

Research Site, Changsha

410013

Research Site, Changsha

411013

Research Site, Pune

412007

Research Site, Zhuzhou

430010

Research Site, Wuhan

430022

Research Site, Wuhan

430033

Research Site, Changsha

440034

Research Site, Penza

450052

Research Site, Zhengzhou

473000

Research Site, Nanyang

510000

Research Site, Guangzhou

510080

Research Site, Guangzhou

510630

Research Site, Guangzhou

510800

Research Site, Guangzhou

511400

Research Site, Guangzhou

518020

Research Site, Shenzhen

523009

Research Site, Dongguan

528000

Research Site, Foshan

530000

Research Site, Huế

541000

Research Site, Guilin

550002

Research Site, Guiyang

550004

Research Site, Guiyang

570311

Research Site, Haikou

600037

Research Site, Chennai

605006

Research Site, Dhanvantari Nagar

610000

Research Site, Chengdu

610500

Research Site, Chengdu

630087

Research Site, Novosibirsk

644000

Research Site, Yibin

644112

Research Site, Omsk

650000

Research Site, Kemerovo

650032

Research Site, Kunming

700000

Research Site, Ho Chi Minh City

712000

Research Site, Xianyang

730000

Research Site, Lanzhou

730030

Research Site, Lanzhou

750004

Research Site, Yinchuan

810000

Research Site, Biên Hòa

3020118

Research Site, Moriya-shi

06002

Research Site, Bloomfield

06762

Research Site, Middlebury

48202-2689

Research Site, Detroit

07305

Research Site, Jersey City

02903

Research Site, Providence

X5016LIG

Research Site, Córdoba

B7600DBZ

Research Site, Mar del Plata

B2700LDK

Research Site, Pergamino

D5700CTA

Research Site, San Luis

L6300

Research Site, Santa Rosa

B1872EEC

Research Site, Sarandí

70390-700

Research Site, Brasília

80230-130

Research Site, Curitiba

80440-020

Research Site, Curitiba

89227-680

Research Site, Joinville

87060-040

Research Site, Maringá

90020-090

Research Site, Porto Alegre

90160-093

Research Site, Porto Alegre

50720-635

Research Site, Recife

14025-170

Research Site, Ribeirão Preto

20551-030

Research Site, Rio de Janeiro

04038-031

Research Site, São Paulo

05024-040

Research Site, São Paulo

05403-9000

Research Site, São Paulo

E2L 4L2

Research Site, Saint John

B3H 2Y9

Research Site, Halifax

B1P 1P3

Research Site, Sydney

L1G 2B9

Research Site, Oshawa

M3M 0B2

Research Site, Toronto

J4V 2H1

Research Site, Greenfield Park

H1T 2M4

Research Site, Montreal

H2T 3B3

Research Site, Montreal

H3T 1E4

Research Site, Montreal

H4J 1C5

Research Site, Montreal

G1R 2J6

Research Site, Québec

030012

Research Site, Taiyuan

CN-830004

Research Site, Ürümqi

370 01

Research Site, České Budějovice

580 22

Research Site, Havlíčkův Brod

514 01

Research Site, Jilemnice

339 01

Research Site, Klatovy

460 63

Research Site, Liberec

692 31

Research Site, Nové Město na Moravě

140 21

Research Site, Prague

390 03

Research Site, Tábor

674 01

Research Site, Třebíč

00168

Research Site, Roma

251-0041

Research Site, Fujisawa-shi

810-0004

Research Site, Fukuoka

434-0018

Research Site, Hamamatsu

210-0852

Research Site, Kawasaki-shi

360-0831

Research Site, Kumagaya-shi

861-8520

Research Site, Kumamoto

600-8216

Research Site, Kyoto

380-0904

Research Site, Nagano

852-8053

Research Site, Nagasaki

901-2393

Research Site, Nakagami-gun

904-2143

Research Site, Okinawa-shi

523-0082

Research Site, Ōmihachiman

306-0433

Research Site, Sashima-gun

158-0094

Research Site, Setagaya-ku

989-0231

Research Site, Shiroishi-shi

865-0016

Research Site, Tamanashi

302-0011

Research Site, Toride-shi

300-0062

Research Site, Tsuchiura-shi

300-0835

Research Site, Tsuchiura-shi

305-0861

Research Site, Tsukuba

300-1296

Research Site, Ushiku-shi

498-0006

Research Site, Yatomi-shi

0 3100

Research Site, Mexico City

CUSCO 01

Research Site, Cusco

LIMA 01

Research Site, Lima

80-462

Research Site, Gdansk

37-300

Research Site, Leżajsk

90-153

Research Site, Lodz

92-213

Research Site, Lodz

20-954

Research Site, Lublin

56-400

Research Site, Oleśnica

32-300

Research Site, Olkusz

43-200

Research Site, Pszczyna

76-200

Research Site, Słupsk

83-110

Research Site, Tczew

05-200

Research Site, Wołomin

50-981

Research Site, Wroclaw

44-240

Research Site, Żory

96-300

Research Site, Żyrardów

945 75

Research Site, Komárno

04011

Research Site, Košice

984 01

Research Site, Lučenec

010 01

Research Site, Žilina

08025

Research Site, Barcelona

Unknown

Research Site, Kaohsiung City

06800

Research Site, Ankara

01004

Research Site, Kyiv

02125

Research Site, Kyiv

03680

Research Site, Kyiv

04107

Research Site, Kyiv

BS105NB

Research Site, Bristol

LE5 4PW

Research Site, Leicester

L9 7AL

Research Site, Liverpool

E1 1BB

Research Site, London

SE1 2PR

Research Site, London

PR2 9HT

Research Site, Preston

M6 8HD

Research Site, Salford

SN6 6NL

Research Site, Swansea

WV10 OQP

Research Site, Wolverhampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY