JPRN-jRCT2031220173
Recruiting
Phase 3
An open-label study to assess safety and efficacy of SZC in paediatric patients with hyperkalaemia - PEDZ-K
Ageishi Yuji0 sites3 target enrollmentJuly 1, 2022
ConditionsHyperkalaemia
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hyperkalaemia
- Sponsor
- Ageishi Yuji
- Enrollment
- 3
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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.
- •3\. Participants (including those receiving a stable peritoneal dialysis regimen) requiring long\-term treatment of hyperkalaemia (chronic hyperkalaemia) in the age cohort 2 years or more, 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:
- •For participants aged 2 years or more, Local Laboratory S\-K\+ level \> 5\.0 mmol/L, for participants aged 1 month to \< 2 years, Local Laboratory S\-K\+ level \> 6\.0 mmol/L and for participants aged 0 to \< 1 month, Local Laboratory S\-K\+ level \> 6\.5 mmol/L at Screening, measured 3 to 14 days prior to first dose of SZC on CP Study Day 1\. This should also be confirmed prior to dosing on Day 1\.
- •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 or less after birth: \< 450 ms
- •b. For participants aged \>3 days to \< 12 years: \< 440 ms
- •c. For participants aged 12 or more 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.
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.
Outcomes
Primary Outcomes
Not specified
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