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

ClinicalTrials.gov ID: NCT03813407

Public ClinicalTrials.gov record NCT03813407. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

View official ClinicalTrials.gov record → Back to search

ClinicalTrials.gov public records Last synced Sep 7, 2026, 6:44 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID: NCT03813407
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: AstraZeneca; Industry
Enrollment: 140 participants

Conditions and interventions

Conditions

Hyperkalaemia

Interventions

Drug

Eligibility (public fields only)

Age range: 0 Years to 18 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 1, 2019
Primary completion: Feb 20, 2030
Completion: Feb 20, 2030
Last update posted: Aug 12, 2026

2019 – 2030

United States locations

U.S. sites: 14
U.S. states: 11
U.S. cities: 14

Facility	City	State	ZIP	Site status
Research Site	Birmingham	Alabama	35233	Recruiting
Research Site	Atlanta	Georgia	30322	Withdrawn
Research Site	Baltimore	Maryland	21287	Recruiting
Research Site	Grand Rapids	Michigan	49503	Withdrawn
Research Site	St Louis	Missouri	63104	Withdrawn
Research Site	Hackensack	New Jersey	07601	Completed
Research Site	New York	New York	10029	Withdrawn
Research Site	Stony Brook	New York	11794	Withdrawn
Research Site	Charlotte	North Carolina	28207	Withdrawn
Research Site	Winston-Salem	North Carolina	27157	Withdrawn
Research Site	Akron	Ohio	44308	Completed
Research Site	Cincinnati	Ohio	45229	Recruiting
Research Site	Columbia	South Carolina	29203	Recruiting
Research Site	Morgantown	West Virginia	26506-7900	Withdrawn

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 56 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03813407, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 12, 2026 · Synced Sep 7, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03813407 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →