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

Recruiting Phase 3 Interventional Study
Hyperkalaemia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
0 – 18
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
140 (estimated)
Sponsor
AstraZeneca · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Provision of written informed consent of the participant or legal representative, and informed assent from the participant (as appropriate) 2. Female or male from birth to \< 18 years of age (for the study duration). 3. Participants (including those receiving a stable periton…
Contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

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