An Open-label Study to Assess Safety and Efficacy of SZC in Paediatric Patients With Hyperkalaemia

PHASE3RecruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

April 2, 2019

Primary Completion Date

June 29, 2026

Study Completion Date

June 29, 2026

Conditions
Hyperkalaemia
Interventions
DRUG

Sodium Zirconium Cyclosilicate (SZC) Reduced Dose Level

Sodium Zirconium Cyclosilicate (SZC) Dose: Paediatric dose based on body weight equivalent to an adult 2.5 g

DRUG

Sodium Zirconium Cyclosilicate (SZC) Dose Level 1 (DL1)

Sodium Zirconium Cyclosilicate (SZC)Paediatric dose based on body weight equivalent to an adult 5 g

DRUG

Sodium Zirconium Cyclosilicate (SZC) Dose Level 2 (DL2)

Sodium Zirconium Cyclosilicate (SZC) Paediatric dose based on body weight equivalent to an adult 10 g

DRUG

Sodium Zirconium Cyclosilicate (SZC) Dose Level 3 (DL3)

Sodium Zirconium Cyclosilicate (SZC) Paediatric dose based on body weight equivalent to an adult 15 g

DRUG

Sodium Zirconium Cyclosilicate (SZC) Dose During 28 Day Maintenance Phase

A 28-day period during which SZC is administered orally once daily (QD) to maintain normokalaemia. A dose titration regimen starting with QD administration of the dose of SZC the participants received TID in the CP will be studied in the MP and continued in the LTMP. The maximum dose that can be used is the calculated body weight equivalent to the 15 g adult dose

Trial Locations (69)

10029

WITHDRAWN

Research Site, New York

11794

WITHDRAWN

Research Site, Stony Brook

21287

RECRUITING

Research Site, Baltimore

27157

WITHDRAWN

Research Site, Winston-Salem

28041

RECRUITING

Research Site, Madrid

28207

WITHDRAWN

Research Site, Charlotte

29203

RECRUITING

Research Site, Columbia

30322

WITHDRAWN

Research Site, Atlanta

35233

RECRUITING

Research Site, Birmingham

40031

SUSPENDED

Research Site, Sumy

44308

COMPLETED

Research Site, Akron

45147

RECRUITING

Research Site, Essen

45229

RECRUITING

Research Site, Cincinnati

49100

SUSPENDED

Research Site, Dnipropetrovsk

49503

NOT_YET_RECRUITING

Research Site, Grand Rapids

61075

SUSPENDED

Research Site, Kharkiv Region

63104

RECRUITING

Research Site, St Louis

65038

WITHDRAWN

Research Site, Odesa

69063

TERMINATED

Research Site, Zaporizhzhia

69120

RECRUITING

Research Site, Heidelberg

100034

RECRUITING

Research Site, Beijing

100045

RECRUITING

Research Site, Beijing

110060

WITHDRAWN

Research Site, New Delhi

122001

NOT_YET_RECRUITING

Research Site, Gūrgaon

200062

RECRUITING

Research Site, Shanghai

201102

RECRUITING

Research Site, Shanghai

230001

WITHDRAWN

Research Site, Hefei

300011

RECRUITING

Research Site, Timișoara

310052

RECRUITING

Research Site, Hangzhou

400014

RECRUITING

Research Site, Chongqing

400370

RECRUITING

Research Site, Cluj-Napoca

410007

RECRUITING

Research Site, Changsha

443095

WITHDRAWN

Research Site, Samara

540136

RECRUITING

Research Site, Târgu Mureş

610000

RECRUITING

Research Site, Chengdu

610041

RECRUITING

Research Site, Chengdu

751019

NOT_YET_RECRUITING

Research Site, Bhubaneshwar

07601

COMPLETED

Research Site, Hackensack

26506-7900

RECRUITING

Research Site, Morgantown

13060-904

RECRUITING

Research Site, Campinas

01228-200

RECRUITING

Research Site, São Paulo

04038-002

RECRUITING

Research Site, São Paulo

T3B 6A8

RECRUITING

Research Site, Calgary

T6G 1C9

WITHDRAWN

Research Site, Edmonton

V6H 3N1

WITHDRAWN

Research Site, Vancouver

H3T1C5

RECRUITING

Research Site, Montreal

D-13353

WITHDRAWN

Research Site, Berlin

113-8431

RECRUITING

Research Site, Bunkyō City

183-8561

RECRUITING

Research Site, Fuchu-shi

813-0017

RECRUITING

Research Site, Fukuoka

211-0063

RECRUITING

Research Site, Kawasaki-shi

650-0047

RECRUITING

Research Site, Kobe

390-8621

RECRUITING

Research Site, Matsumoto-shi

903-0215

RECRUITING

Research Site, Nakagami-gun

330-8777

RECRUITING

Research Site, Saitama-Shi

989-3126

RECRUITING

Research Site, Sendai

420-8660

RECRUITING

Research Site, Shizuoka

15-274

COMPLETED

Research Site, Bialystok

30-663

WITHDRAWN

Research Site, Krakow

93-338

COMPLETED

Research Site, Lodz

02-097

RECRUITING

Research Site, Warsaw

022322

RECRUITING

Research Site, Bucharest

077120

WITHDRAWN

Research Site, Bucharest

08950

RECRUITING

Research Site, Esplugues de Llobregat

04050

SUSPENDED

Research Site, Kyiv

G51 4TF

RECRUITING

Research Site, Glasgow

SO16 6YD

RECRUITING

Research Site, Hampshire

M13 9WL

COMPLETED

Research Site, Manchester

NG7 2UH

RECRUITING

Research Site, Nottingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY