A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia

PHASE3TerminatedINTERVENTIONAL
Enrollment

716

Participants

Timeline

Start Date

September 30, 2021

Primary Completion Date

February 7, 2024

Study Completion Date

February 7, 2024

Conditions
Renal Insufficiency, ChronicHyperkalemia
Interventions
DRUG

Sodium Zirconium Cyclosilicate (SZC)

"Powder for oral suspension in a sachet. Unit dose strength: 5 or 10 g SZC. Single dose will consist of 1-3 sachets.~During Initiation Phase:~* S-K \> 5 to ≤ 6.5 mmol/L (measured by L-Lab): Single dose contains 10 g SZC that should be suspended in 45 mL of water. The 10 g SZC single dose should be administered three times daily for up to 72 hours until normokalaemic (S-K 3.5-5.0 mmol/L); the total daily dose is 30 g SZC.~* S-K ≥ 3.5 to ≤ 5 mmol/L (measured by L-Lab): Single dose contains 5 g SZC that should be suspended in 45 mL of water and administered once daily for 48 hours.~During Run-in and Maintenance Phases:~\- Single dose contains 5 g SZC administered every other day or 5, 10, or 15 g SZC administered once daily that should be suspended in 45 mL of water."

DRUG

Placebo

"Powder for oral suspension in a sachet. Placebo to match 5 or 10 g. Single dose will consist of 1-3 sachets.~During Maintenance Phase:~\- Single dose contains 5 g placebo administered every other day or 5, 10, or 15 g placebo administered once daily that should be suspended in 45 mL of water."

DRUG

Lisinopril

Tablet for oral administration. Unit dose strength: 2.5, 5, 10 or 20 mg. Dosage level: 5, 10, 20, or 40 mg administered once daily.

DRUG

Valsartan

Tablet or capsule for oral administration. Unit dose strength: 40, 80 or 160 mg. Dosage level: 40, 80, 160, or 320 mg administered once daily.

DRUG

Irbesartan

"Tablet for oral administration. Unit dose strength: 75, 150 or 300 mg. Dosage level: 75, 150, or 300 mg administered once daily.~The study is designed to use valsartan as the selected ARB therapy adjunct to SZC. However, if an actual shortage of valsartan in a local market jeopardises the ability of participants to enter or continue in the study, valsartan can be temporarily substituted with irbesartan until the shortage of valsartan is resolved."

Trial Locations (276)

110

Research Site, Taipei

114

Research Site, Taipei

333

Research Site, Taoyuan District

710

Research Site, Tainan City

833

Research Site, Kaohsiung City

1900

Research Site, La Plata

2000

Research Site, Rosario

Research Site, Samokov

2140

Research Site, Botevgrad

2600

Research Site, Dupnitsa

2700

Research Site, Blagoevgrad

2800

Research Site, Sandanski

2900

Research Site, Gotse Delchev

3320

Research Site, Kozloduy

3600

Research Site, Lom

3700

Research Site, Smolyan

4000

Research Site, Plovdiv

4001

Research Site, Plovdiv

4004

Research Site, Plovdiv

4009

Research Site, Almería

5000

Research Site, Iloilo City

5006

Research Site, San Vicente

5100

Research Site, Gorna Oryahovitsa

5460

Research Site, Alor Star

5800

Research Site, Pleven

6000

Research Site, Stara Zagora

6230

Research Site, Ankara

7500

Research Site, Silistra

7600

Research Site, Mar del Plata

8003

Research Site, Barcelona

8600

Research Site, Yambol

8800

Research Site, Sliven

10000

Research Site, Ho Chi Minh City

10002

Research Site, Taipei

Research Site, Zhytomyr

10330

Research Site, Bangkok

10400

Research Site, Ratchathewi

10700

Research Site, Bangkok

11021

Research Site, Great Neck

12205

Research Site, Albany

18017

Research Site, Bethlehem

19013

Research Site, Chester

20089

Research Site, Rozzano

20448

Research Site, Keelung

21028

Research Site, Vinnytsia

23561

Research Site, New Taipei City

23606

Research Site, Newport News

25123

Research Site, Brescia

27004

Research Site, Lugo

27100

Research Site, Pavia

27103

Research Site, Winston-Salem

27310

Research Site, Gaziantep

28040

Research Site, Madrid

28905

Research Site, Getafe

29118

Research Site, Orangeburg

29203

Research Site, Columbia

32040

Research Site, Seri Manjung

33012

Research Site, Hialeah

33313

Research Site, Lauderdale Lakes

33435

Research Site, Boynton Beach

33637

Research Site, Temple Terrace

34761

Research Site, Ocoee

35040

Research Site, Izmir

36061

Research Site, Bassano del Grappa

37126

Research Site, Verona

37404

Research Site, Chattanooga

38010

Research Site, Santa Cruz de Tenerife

38039

Research Site, Kayseri

40138

Research Site, Bologna

40201

Research Site, Taichung

40205

Research Site, Louisville

40705

Research Site, Taichung

41009

Research Site, Seville

41380

Research Site, Kocaeli

43000

Research Site, Kajang

43005

Research Site, Lutsk

44670

Research Site, Guadalajara

45267

Research Site, Cincinnati

46010

Research Site, Valencia

46014

Research Site, Valencia

46100

Research Site, Kahramanmaraş

46804

Research Site, Fort Wayne

48081

Research Site, Saint Clair Shores

48532

Research Site, Flint

49005

Research Site, Dnipropetrovsk

50200

Research Site, Chaingmai

50586

Research Site, Kuala Lumpur

54100

Research Site, Adapazarı

55000

Research Site, Da Nang

56000

Research Site, Kuala Lumpur

59100

Research Site, Kuala Lumpur

60523

Research Site, Oak Brook

60643

Research Site, Chicago

61039

Research Site, Kharkiv

64111

Research Site, Kansas City

65201

Research Site, Columbia

68100

Research Site, Batu Caves

69001

Research Site, Zaporizhzhia

70000

Research Site, Ho Chi Minh City

70124

Research Site, Bari

70403

Research Site, Tainan City

71013

Research Site, San Giovanni Rotondo

76015

Research Site, Arlington

76164

Research Site, Fort Worth

77004

Research Site, Houston

77054

Research Site, Houston

77099

Research Site, Houston

78212

Research Site, San Antonio

78250

Research Site, San Luis Potosí City

80100

Research Site, Johor Bahru

80230

Research Site, Denver

Research Site, Culiacán

81362

Research Site, Kaohsiung City

82000

Research Site, Mazatlán

82445

Research Site, Kaohsiung City

83687

Research Site, Nampa

85374

Research Site, Surprise

85741

Research Site, Tucson

87109

Research Site, Albuquerque

90110

Research Site, Hat Yai

90280

Research Site, South Gate

91324

Research Site, Northridge

91351

Research Site, Canyon Country

91356

Research Site, Tarzana

91773

Research Site, San Dimas

91900

Research Site, Veracruz

91910

Research Site, Chula Vista

97002

Research Site, Hualien City

97070

Research Site, Mérida

97130

Research Site, Mérida

98125

Research Site, Messina

100000

Research Site, Hanoi

100029

Research Site, Beijing

100034

Research Site, Beijing

100044

Research Site, Beijing

100191

Research Site, Beijing

102206

Research Site, Beijing

102218

Research Site, Beijing

110001

Research Site, Shenyang

110004

Research Site, Shengyang

110029

Research Site, New Delhi

123182

Research Site, Moscow

130041

Research Site, Changchun

191167

Research Site, Saint Petersburg

200025

Research Site, Shanghai

200040

Research Site, Shanghai

201199

Research Site, Shanghai

201210

Research Site, Shanghai

210009

Research Site, Nanjing

210011

Research Site, Nanjing

210029

Research Site, Nanjing

214023

Research Site, Wuxi

220216

Research Site, New Taipei City

221000

Research Site, Xuzhou

230601

Research Site, Hefei

264000

Research Site, Yantai

310014

Research Site, Hangzhou

315010

Research Site, Ningbo

330006

Research Site, Nanchang

344022

Research Site, Rostov-on-Don

400010

Research Site, Chongqing

410013

Research Site, Changsha

412007

Research Site, Zhuzhou

421001

Research Site, Hengyang

430010

Research Site, Wuhan

430060

Research Site, Wuhan

510000

Research Site, Guangzhou

510062

Research Site, Guangzhou

510180

Research Site, Guangzhou

510630

Research Site, Guangzhou

515041

Research Site, Shantou

516001

Research Site, Huizhou

518036

Research Site, Shenzhen

530000

Research Site, Huế

550002

Research Site, Guiyang

572000

Research Site, Sanya

610041

Research Site, Chengdu

610072

Research Site, Chengdu

614000

Research Site, Perm

624002

Research Site, Aramil

625107

Research Site, Madurai

641018

Research Site, Coimbatore

700000

Research Site, Ho Chi Minh City

700020

Research Site, Kolkata

710061

Research Site, Xi'an

730030

Research Site, Lanzhou

750004

Research Site, Yinchuan

810000

Research Site, Biên Hòa

830054

Research Site, Ürümqi

60115282

Research Site, Fortaleza

02114

Research Site, Boston

02115

Research Site, Boston

ARG 1425

Research Site, Buenos Aires

C1429BWN

Research Site, Buenos Aires

C1440AAD

Research Site, CABA

B7600

Research Site, Mar del Plata

B1872EEC

Research Site, Sarandí

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

04039-000

Research Site, São Paulo

05403-9000

Research Site, São Paulo

E2L 4L2

Research Site, Saint John

L1G 2B9

Research Site, Oshawa

H1T 2M4

Research Site, Montreal

H4J 1C5

Research Site, Montreal

014010

Research Site, Baotou

030012

Research Site, Taiyuan

Unknown

Research Site, Zhengzhou

Research Site, Istanbul

00161

Research Site, Roma

00168

Research Site, Roma

660-8550

Research Site, Amagasaki-shi

243-0035

Research Site, Atsugi-shi

260-8712

Research Site, Chiba

409-3898

Research Site, Chuo-shi

103-0002

Research Site, Chūōku

104-8560

Research Site, Chūōku

814-0180

Research Site, Fukuoka

247-0056

Research Site, Kamakura-shi

893-0015

Research Site, Kanoya-shi

486-8510

Research Site, Kasugai-shi

586-8521

Research Site, Kawachinagano-shi

211-8510

Research Site, Kawasaki-shi

805-8508

Research Site, Kitakyushu

802-8555

Research Site, Kitakyushu-shi

963-8052

Research Site, Koriyama-shi

343-8555

Research Site, Koshigaya-shi

861-8520

Research Site, Kumamoto

737-0023

Research Site, Kure-shi

763-8502

Research Site, Marugame-shi

390-8621

Research Site, Matsumoto-shi

515-8557

Research Site, Matsusaka-shi

790-8524

Research Site, Matsuyama

457-8511

Research Site, Nagoya

466-8650

Research Site, Nagoya

311-0113

Research Site, Naka

278-8501

Research Site, Noda

543-8922

Research Site, Osaka

559-0012

Research Site, Osaka

870-0033

Research Site, Ōita

523-0082

Research Site, Ōmihachiman

593-8304

Research Site, Sakaishi

665-0873

Research Site, Takarazuka-shi

470-0396

Research Site, Toyota

471-8513

Research Site, Toyota-Shi

514-8507

Research Site, Tsu

300-0028

Research Site, Tsuchiura-shi

279-0021

Research Site, Urayasu-shi

425-8505

Research Site, Yaizu-shi

227-8501

Research Site, Yokohama

234-0054

Research Site, Yokohama

236-0004

Research Site, Yokohama

683-8605

Research Site, Yonago-shi

06700

Research Site, Cuauhtémoc

Research Site, México

03100

Research Site, México

PH-8000

Research Site, Davao City

31-156

Research Site, Krakow

92-213

Research Site, Lodz

61-485

Research Site, Poznan

35-055

Research Site, Rzeszów

83-110

Research Site, Tczew

00717

Research Site, Ponce

08035

Research Site, Barcelona

08036

Research Site, Barcelona

08907

Research Site, L'Hospitalet de Llobregat

06230

Research Site, Ankara

06340

Research Site, Ankara

07059

Research Site, Antalya

02125

Research Site, Kyiv

03057

Research Site, Kyiv

04050

Research Site, Kyiv

04053

Research Site, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY