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NCT03813407 · ClinicalTrials.gov registry record · Phase 3
An Open-label Study to Assess Safety and Efficacy of SZC in Paediatric Patients With Hyperkalaemia
A Phase 3 study of Hyperkalaemia, sponsored by AstraZeneca.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 140
- Enrollment target
- 20
- Study locations
NCT03813407 is a Phase 3 study of Hyperkalaemia that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 140 participants. The trial reports 20 study locations across 14 states.
The verdict
NCT03813407, a Phase 3 study of Hyperkalaemia, is actively recruiting participants, sponsored by AstraZeneca.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 140 participants
- Enrollment target
- 20
- Study locations
Study 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
Conditions Studied
Interventions
- DRUG Sodium Zirconium Cyclosilicate (SZC) Reduced Dose Level
- DRUG 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
Study Locations (20)
Other
- Research Site - Campinas
- Research Site - São Paulo
- Research Site - São Paulo
New York
- Research Site - New York
- Research Site - Stony Brook
North Carolina
- Research Site - Charlotte
- Research Site - Winston-Salem
Ohio
- Research Site - Akron
- Research Site - Cincinnati
Alberta
- Research Site - Calgary
- Research Site - Edmonton
Alabama
- Research Site - Birmingham
Georgia
- Research Site - Atlanta
Maryland
- Research Site - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2019-04-02 |
| Est. Completion | 2030-02-21 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03813407
The ClinicalTrials.gov registry entry for NCT03813407 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hyperkalaemia appearing as the primary indexed condition, and to 5 interventions - of which Sodium Zirconium Cyclosilicate (SZC) Reduced Dose Level is the first listed.
NCT03813407 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Other, New York, North Carolina.
Frequently Asked Questions
What is clinical trial NCT03813407 about?
NCT03813407 is a clinical study titled "An Open-label Study to Assess Safety and Efficacy of SZC in Paediatric Patients With Hyperkalaemia". 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 hyperk...
What is the current status of trial NCT03813407?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 140 participants. The study started on 2019-04-02. Estimated completion is 2030-02-21.
What conditions does trial NCT03813407 study?
This clinical trial studies the following conditions: Hyperkalaemia.
What interventions are being tested in trial NCT03813407?
The interventions under investigation include: Sodium Zirconium Cyclosilicate (SZC) Reduced Dose Level (DRUG), 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 (DRUG).
Who is sponsoring clinical trial NCT03813407?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03813407 being conducted?
This trial has 20 study locations across Alabama, Georgia, Maryland, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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