Dose-Escalating Study to Evaluate SZC in Children with Hyperkalaemia
Research type
Research Study
Full title
A Phase 3, Dose-Escalating Study in Children With Hyperkalaemia Between Birth and <18 Years of Age to Evaluate Increasing Doses of Sodium Zirconium Cyclosilicate (SZC) Given Three Times Daily for the Correction of Hyperkalaemia and the Effectiveness of the Same Dose of SZC Given Once Daily to Maintain Normokalaemia Among Those Requiring Continuous Treatment.
IRAS ID
251086
Contact name
Laura Taylor
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2018-001331-48
Duration of Study in the UK
1 years, 8 months, 7 days
Research summary
Sodium zirconium cyclosilicate (SZC) has been shown to be effective and safe in adults for the treatment of hyperkalaemia. Hyperkalaemia is the term used for high potassium levels in the blood. Hyperkalaemia is a potentially life-threatening condition and requires treatment to promptly lower blood potassium levels. Treatments currently available for hyperkalaemia either do not have available safety data for long-term use or are currently under development for treatment in children.
Since SZC has been shown to be effective and safe in adults, it is expected to be beneficial in children. This study will evaluate the effectiveness, safety and tolerability of SZC for the treatment of hyperkalaemia in children less than 18 years of age.
The research study is planned to go on for around 30 months and will include around 100 paediatric patients with hyperkalaemia from about 6 - 9 countries.
Participants will attend approximately 10 to 14 visits over 5 to 27 weeks, depending on the treatment phases they take part in. Study visits may include any of the following procedures: physical examination; measurement of blood pressure, temperature, heart rate, and weight; blood and urine sample collection for laboratory tests; and ECGs (electrocardiograms). Required procedures may vary depending on the age of the participant.
The study is sponsored by AstraZeneca AB and is planned to run at 3 hospitals in the UK.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
19/EM/0014
Date of REC Opinion
18 Mar 2019
REC opinion
Further Information Favourable Opinion