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Assessing the safety and efficacy of sodium zirconium cyclosilicate in children with hyperkalaemia

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

Phase 3 Interventional AstraZeneca · NCT03813407

This study is testing a new medication called sodium zirconium cyclosilicate to see if it can safely help children with high potassium levels feel better and keep their potassium in a normal range.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment140 (estimated)
Ages0 Years to 18 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Locations69 sites (Birmingham, Alabama and 68 other locations)
Trial IDNCT03813407 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, efficacy, and tolerability of sodium zirconium cyclosilicate (SZC) for treating hyperkalaemia in pediatric patients under 18 years of age. It includes a Correction Phase where participants will receive SZC three times daily for up to three days, followed by a Maintenance Phase to assess the ability to maintain normal potassium levels. The study will enroll approximately 140 participants across multiple sites in Europe and North America, with specific cohorts based on age. The study aims to gather data on the drug's effectiveness in achieving and maintaining normokalaemia in children.

Who should consider this trial

Good fit: Ideal candidates include children from birth to under 18 years of age with chronic or acute hyperkalaemia.

Not a fit: Patients who do not have hyperkalaemia or those who are not within the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safe and effective option for managing hyperkalaemia in children.

How similar studies have performed: Previous studies have shown sodium zirconium cyclosilicate to be effective in adults, suggesting potential success in pediatric populations, although this specific application is novel.

Eligibility criteria

Show full inclusion / exclusion 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 peritoneal dialysis regimen for a minimum of 2 months) requiring long-term treatment of hyperkalaemia (chronic hyperkalaemia) in the age cohort ≥ 2 years, and participants requiring either short- or long-term treatment for hyperkalaemia (acute and chronic hyperkalaemia) in the age cohort \< 2 years.
4. Participants must meet the following criteria for hyperkalaemia: Please refer to the Table 6 in the protocol.
5. Using digital ECG, QT interval corrected by Bazett's method (QTcB) must meet the age-appropriate parameters at Screening: a. For participants aged 0 to ≤ 3 days after birth: \< 450 ms b. For participants aged \>3 days to \< 12 years: \< 440 ms c. For participants aged ≥ 12 to \< 18 years: \< 450 ms (male), \< 460 ms (female) All QTcB values outside the reference values specified in the protocol should be manually re-measured and re-calculated, and if there is a difference in measurement between the automatic and manual ECG, the manual measurement should always be considered correct.
6. Ability to have repeated blood draws or effective venous catheterisation.
7. Females of childbearing potential (defined as a female with potential of becoming pregnant who has experienced her menarche) must have a negative pregnancy test within one day prior to the first dose of SZC on CP Study Day 1 and sexually active females of childbearing potential must be using 2 forms of medically acceptable contraception with at least one being a barrier method
8. Optional open-label, LTMP only:

   1. Provision of written informed consent of the participant or legal representative, and informed assent from the participant (as appropriate) to take part in the LTMP.
   2. Participants who are normokalaemic at the end of MP or hyperkalaemic and not on maximum dose.
   3. Participants who would benefit from long-term treatment for their hyperkalaemia, as judged by the Investigator.

Exclusion Criteria:

1. Neonates with a gestational age \< 37 weeks at birth or a birth weight \< 2500 g.
2. Term and preterm neonates with suspected conditions predisposing them to intestinal ischaemia (eg, perinatal hypoxia or sepsis).
3. Participants with pseudohyperkalaemia caused by excessive fist clenching to enable venepuncture, by haemolysed blood specimens, or by severe leukocytosis or thrombocytosis.
4. Participants with hyperkalaemia due to soft-tissue damage from crush injury or burns. 5. Participants with hyperkalaemia due to a secondary cause, such as dehydration, excessive use of K+ supplements, or drug use (eg, beta-adrenergic antagonists) and that would be more appropriately treated with other interventions (eg, fluid resuscitation, dose adjustments of medications).

6\. Participants with transient iatrogenic hyperkalaemia (eg, due to treatment with tacrolimus).

7\. Participants treated with lactulose, rifaximin (XIFAXAN™), or other nonabsorbed antibiotics for hyperammonaemia within the last 7 days.

8\. Participants treated with CPS, sodium polystyrene sulfonate (eg, KAYEXALATE™), or patiromer within the last 4 days prior to first dose of study treatment.

9\. Participants with a life expectancy of less than 3 months. 10. Participants who are known to have tested Human Immunodeficiency Virus (HIV) positive.

11\. Presence of any condition which, in the opinion of the Investigator, places the participant at undue risk or potentially jeopardises the quality of the data to be generated. 12. Known hypersensitivity or previous anaphylaxis to SZC or to components thereof.

13\. Participants with cardiac arrhythmias that require immediate treatment. 14. Participants with a family history of long QT syndrome. 15. Participants on haemodialysis. 16. Participants with a history of bowel obstruction. 17. Participants with severe gastrointestinal disorder or major gastrointestinal surgery (eg, large bowel resection).

18\. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).

19\. Previous treatment with SZC. 20. Treatment with a drug or device within the last 30 days prior to first dose of study treatment that has not received regulatory approval at the time of study entry.

21\. Previous enrolment in the present study. 22. Females who are pregnant, breastfeeding, or planning to become pregnant. 23. Judgement by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements. 24. If the participant has evidence of Coronavirus disease 2019 (COVID-19) within 2 weeks prior to enrolment (a positive COVID-19 test or suspicion of COVID-19 infection) the participant cannot be enrolled in the study.

Where this trial is running

Birmingham, Alabama and 68 other locations

+19 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hyperkalaemiasodium zirconium cyclosilicateHyperkalaemia in children
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.