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Tests treatment safety and results for Hyperkalaemia
Official title An Open-label Study to Assess Safety and Efficacy of SZC in Paediatric Patients With Hyperkalaemia
ClinicalTrials.gov ID: NCT03813407
What this study is testing
What is Sodium Zirconium Cyclosilicate (SZC) Reduced Dose Level?
Sodium Zirconium Cyclosilicate (SZC) Reduced Dose Level is an investigational medicine, given as an once-daily, being studied as a potential treatment for hyperkalaemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 22 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 18
You may be able to join if
- Provision of written informed consent of the participant or legal representative, and informed assent from the participant (as appropriate)
- Female or male from birth to \< 18 years of age (for the study duration).
- Participants (including those receiving a stable peritoneal dialysis regimen for a minimum of 2 months) requiring long-term treatment of...
- Participants must meet the following criteria for hyperkalaemia: Please refer to the Table 6 in the protocol.
- Using digital ECG, QT interval corrected by Bazett's method (QTcB) must meet the age-appropriate parameters at Screening: a. For participants aged 0...
You likely can't join if
- Neonates with a gestational age \< 37 weeks at birth or a birth weight \< 2500 g.
- Term and preterm neonates with suspected conditions predisposing them to intestinal ischaemia (eg, perinatal hypoxia or sepsis).
- Participants with pseudohyperkalaemia caused by excessive fist clenching to enable venepuncture, by haemolysed blood specimens, or by severe...
- Participants with hyperkalaemia due to soft-tissue damage from crush injury or burns. 5. Participants with hyperkalaemia due to a secondary cause...
See the full eligibility criteria
- Provision of written informed consent of the participant or legal representative, and informed assent from the participant (as appropriate)
- Female or male from birth to \< 18 years of age (for the study duration).
- 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 must meet the following criteria for hyperkalaemia: Please refer to the Table 6 in the protocol.
- 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: \ 3 days to \< 12 years: \< 440 ms c. For...
- Ability to have repeated blood draws or effective venous catheterisation.
- 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...
- Optional open-label, LTMP only:
- 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.
- Participants who are normokalaemic at the end of MP or hyperkalaemic and not on maximum dose.
- Participants who would benefit from long-term treatment for their hyperkalaemia, as judged by the Investigator.
- Neonates with a gestational age \< 37 weeks at birth or a birth weight \< 2500 g.
- Term and preterm neonates with suspected conditions predisposing them to intestinal ischaemia (eg, perinatal hypoxia or sepsis).
- Participants with pseudohyperkalaemia caused by excessive fist clenching to enable venepuncture, by haemolysed blood specimens, or by severe leukocytosis or thrombocytosis.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Atlanta, Georgia, United States
- Baltimore, Maryland, United States
- Grand Rapids, Michigan, United States
- St Louis, Missouri, United States
- Hackensack, New Jersey, United States
- New York, New York, United States
- Stony Brook, New York, United States
- Charlotte, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Akron, Ohio, United States
- Cincinnati, Ohio, United States
- Columbia, South Carolina, United States
- Morgantown, West Virginia, United States
- Campinas, Brazil
- São Paulo, Brazil
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
- Vancouver, British Columbia, Canada
- Montreal, Quebec, Canada
+ 45 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 22 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 0 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Atlanta, Georgia, United States; Baltimore, Maryland, United States; Grand Rapids, Michigan, United States; St Louis, Missouri, United States; Hackensack, New Jersey, United States and 59 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.