An Open-label Study to Assess Safety and Efficacy of SZC in Paediatric Patients With Hyperkalaemia
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Sodium Zirconium Cyclosilicate (SZC) Dose Level 1 (DL1): Sodium Zirconium Cyclosilicate (SZC)Paediatric dose based on body weight equivalent to an adult 5 g
Sodium Zirconium Cyclosilicate (SZC) Dose Level 2 (DL2): Sodium Zirconium Cyclosilicate (SZC) Paediatric dose based on body weight equivalent to an adult 10 g
Sodium Zirconium Cyclosilicate (SZC) Dose Level 3 (DL3): Sodium Zirconium Cyclosilicate (SZC) Paediatric dose based on body weight equivalent to an adult 15 g
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
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 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
Eligibility
Primary outcome measure(s)
- 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 — 3 days
Normokalaemia achieved in the CP within 3 days (yes/no) - 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 — last two scheduled visits in the MP
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
Trial sites (70)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Birmingham | Alabama | Recruiting |
| Research Site | Atlanta | Georgia | Withdrawn |
| Research Site | Baltimore | Maryland | Recruiting |
| Research Site | Grand Rapids | Michigan | Withdrawn |
| Research Site | St Louis | Missouri | Withdrawn |
| Research Site | Hackensack | New Jersey | Completed |
| Research Site | New York | New York | Withdrawn |
| Research Site | Stony Brook | New York | Withdrawn |
| Research Site | Charlotte | North Carolina | Withdrawn |
| Research Site | Winston-Salem | North Carolina | Withdrawn |
| Research Site | Akron | Ohio | Completed |
| Research Site | Cincinnati | Ohio | Recruiting |
| Research Site | Columbia | South Carolina | Recruiting |
| Research Site | Morgantown | West Virginia | Withdrawn |
| Research Site | Campinas | Brazil | Recruiting |
| Research Site | São Paulo | Brazil | Recruiting |
| Research Site | São Paulo | Brazil | Recruiting |
| Research Site | Calgary | Alberta | Recruiting |
| Research Site | Edmonton | Alberta | Withdrawn |
| Research Site | Vancouver | British Columbia | Withdrawn |
| Research Site | Montreal | Quebec | Recruiting |
| Research Site | Beijing | China | Recruiting |
| Research Site | Beijing | China | Recruiting |
| Research Site | Changsha | China | Recruiting |
| Research Site | Chengdu | China | Recruiting |
| Research Site | Chengdu | China | Recruiting |
| Research Site | Chongqing | China | Recruiting |
| Research Site | Hangzhou | China | Recruiting |
| Research Site | Hefei | China | Withdrawn |
| Research Site | Shanghai | China | Recruiting |
| Research Site | Shanghai | China | Recruiting |
| Research Site | Berlin | Germany | Withdrawn |
| Research Site | Essen | Germany | Recruiting |
| Research Site | Heidelberg | Germany | Recruiting |
| Research Site | Bhubaneswar | India | Recruiting |
| Research Site | Gurgaon | India | Recruiting |
| Research Site | New Delhi | India | Withdrawn |
| Research Site | Bunkyō City | Japan | Recruiting |
| Research Site | Fuchu-shi | Japan | Withdrawn |
| Research Site | Fukuoka | Japan | Withdrawn |
+ 30 more sites — see the full list on the official registry below.
More AstraZeneca trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03813407 on ClinicalTrials.gov ↗ ← All trials in Spain