Brief Summary

Sodium zirconium cyclosilicate has been shown to be effective and safe in adults for the treatment of hyperkalaemia, and therefore it is expected to be beneficial in children. This study will evaluate the efficacy, safety and tolerability of sodium zirconium cyclosilicate for the treatment of hyperkalaemia in children \<18 years of age. Approximately 140 participants will enter CP at approximately 46 sites in locations including but not limited to Europe and North America for this study. Treatment will include 3 phases: the CP, MP, and LTMP. Enrolment will start in 2 cohorts, ages 6 to \< 12 years and 12 to \< 18 years. After review of accumulated data, the independent Data Monitoring Committee (iDMC) will recommend whether to open enrolment in the ages 2 to \< 6 years cohort and later in the ages 0 to \< 2 years cohort. All eligible participants with hyperkalaemia will enter an open-label Correction Phase (CP) receiving a fixed dose of SZC three times daily (TID) for up to 3 days until normokalaemia is achieved. Within each age cohorts 2 to \< 18 years, initial participants will be allocated to the dose level (DL) based on body weight equivalent to an adult 5 g TID. After recommendation of higher DLs by the iDMC, subsequent participants may be allocated in the CP to on body weight equivalent to an adult 10 g TID and then potentially on body weight equivalent to an adult 15 g TID. All participants in the ages 0 to \< 2 years cohort will be assigned to the same DL which will be decided based on data from older age cohorts. Participants who successfully achieve normokalaemia in the CP will enter a 28-day open-label Maintenance Phase (MP), which will be initiated with once daily administration of the dose received TID in the CP. During MP, the Investigator is able to titrate the dose up or down in the range 2.5 g to 15 g body weight equivalent to maintain normokalaemia. For participants who, at the end of MP, are normokalaemic or hyperkalaemic without being on maximum dose, the MP is followed by the option to continue the study in a long term maintenance phase (LTMP) where the same titration regimen is used as in MP

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

140

participants targeted

Target at P25-P50 for phase_3

Timeline

47mo left

Started Apr 2019

Longer than P75 for phase_3

Geographic Reach

13 countries

69 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

10.9 years study duration

Study Progress65%

Apr 2019Feb 2030

First Submitted

Initial submission to the registry

November 22, 2018

Completed

2 months until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed

2 months until next milestone

Study Start

First participant enrolled

April 2, 2019

Completed

10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2030

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2030

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

10.9 years

First QC Date

November 22, 2018

Last Update Submit

April 16, 2026

Conditions

Hyperkalaemia

Keywords

sodium zirconium cyclosilicateHyperkalaemia in children

Outcome Measures

Primary Outcomes (2)

Correction phase (CP) primary objective: To evaluate the ability to achieve normokalaemia during the CP when initiating treatment with SZC of different dose levels in children with hyperkalaemia
Normokalaemia achieved in the CP within 3 days (yes/no)
3 days
28-day Maintenance Phase (MP) primary objective: To evaluate the ability to maintain normokalaemia during the MP when continuing SZC treatment in children achieving normokalaemia
28-day MP primary endpoint: Serum potassium (S-K+) value within normokalaemia range (yes/no) at each of the last two scheduled visits in the MP
last two scheduled visits in the MP

Secondary Outcomes (4)

All phases secondary objective: To evaluate the change in S-K+ in children treated with SZC
at each scheduled visit
MP secondary objectives: To evaluate change in serum aldosterone levels in children treated with SZC during the MP
from baseline to Week 3 of the MP
MP Secondary objective: To evaluate change in serum electrolytes (including bicarbonate), spot urinary pH and urinary electrolytes levels in children treated with SZC during the MP
from baseline to week 3 of the MP
Long-term MP (LTMP) secondary objectives: To evaluate the ability of maintaining normokalaemia in children treated with SZC during the LTMP
at each scheduled visit

Other Outcomes (2)

Safety objective: To evaluate the safety and tolerability of SZC in the 3 phases (CP, MP and LTMP)
Throughout the study, 27 weeks
Tertiary/Exploratory objective: To evaluate the acceptability and palatability of SZC through the study
At certain timepoints throughout the study

Study Arms (1)

Active Arm ( Sodium Zirconium Cyclosilicate SZC)

EXPERIMENTAL

Dosage formulation: 5 g sachets 2.5 g sachets 0.25 g sprinkle capsules 0.125 g sprinkle capsules (can be manufactured to support participants \<2 years of age) Route of administration: Oral Dosing instructions: SZC is provided as a powder. At the time of dosing SZC is mixed with a quantity of water or sprinkled onto semi-solid food (eg, milk, baby food, yogurt, or ice cream) within an hour of drug administration. Packaging and labelling: Study treatment will be provided in sachets packed in cartons or sprinkle capsules in high density polyethylene bottles, as appropriate for the dose. Each carton of sachets, individual sachets, and bottle of capsules will be labelled in accordance with Good Manufacturing Practice Annex 13 and per country regulatory requirement. Participant-specific dosing cards (diary) will be provided.

Drug: Sodium Zirconium Cyclosilicate (SZC) Reduced Dose LevelDrug: Sodium Zirconium Cyclosilicate (SZC) Dose Level 1 (DL1)Drug: Sodium Zirconium Cyclosilicate (SZC) Dose Level 2 (DL2)Drug: Sodium Zirconium Cyclosilicate (SZC) Dose Level 3 (DL3)Drug: Sodium Zirconium Cyclosilicate (SZC) Dose During 28 Day Maintenance Phase

Interventions

Sodium Zirconium Cyclosilicate (SZC) Reduced Dose LevelDRUG

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