An open-label study to assess safety and efficacy of SZC in paediatric patients with hyperkalaemia

AstraZeneca AB0 sites140 target enrollmentApril 9, 2019

Overview

No summary available.

Registry

who.int

Start Date

April 9, 2019

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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\. 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.

•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.