A study to investigate increasing doses of Sodium Zirconium Cycloscilicate (SZC) in children under 18 years old who have high blood potassium levels (Hyperkalaemia ). Patients will take SZC each day (in one or three doses), until normal blood potassium levels are reached (Normokalaemia)
- Conditions
- HyperkalaemiaMedDRA version: 21.1Level: LLTClassification code 10020647Term: HyperkalemiaSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2018-001331-48-GB
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 140
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 peritoneal dialysis) requiring long term treatment of hyperkalaemia (chronic hyperkalaemia) in the age cohort =2 years, and participants requiring either short- or longterm treatment for hyperkalaemia (acute and chronic hyperkalaemia) in the age cohort <2 years..
4. Participants must meet 1 of the following criteria for hyperkalaemia:
(a)For participants =2 years of age, mean i STAT K+ level >5.0 mmol/L
at Screening. Two consecutive i STAT K+ values, measured 60 (±15)
minutes apart, both >5.0 mmol/L and measured within 1 day before the first dose of SZC on CP Study Day 1.
(b)For participants <2 years of age, i STAT K+ level >6.0 mmol/L at
Screening, measured within 1 day before the first dose of SZC on CP
Study Day 1.
Note that if Day 1 is the same as the Screening day, the 60 (±15) minute K+ value is the same as the Day 1 time 0 K+ value. However, if Day 1 is not the same day as Screening, then the participant will actually have 3 i STAT-K+ values measured before starting treatment in the CP and the third value which is taken on Day 1 time 0 must also be hyperkalaemic.
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 =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 catheterization.
7. Females of childbearing potential must have a negative pregnancy test within 1 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 1 being a barrier method
Are the trial subjects under 18? yes
Number of subjects for this age range: 140
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 ischemia (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, betaadrenergic antagonists) and that would be more appropriately treated with other interventions (eg, fluid resuscitation, dose adjustments of medications)
6. Participants treated with lactulose, rifaximin (XIFAXAN™), or other
nonabsorbed antibiotics for hyperammonaemia within the last 7 days.
7. Participants treated with CPS, sodium polystyrene sulfonate (eg,
KAYEXALATE™), or patiromer within the last 4 days.
8. Participants with a life expectancy of less than 3 months.
9. Participants who are known to have tested Human Immunodeficiency Virus (HIV) positive.
10. 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.
11. Known hypersensitivity or previous anaphylaxis to SZC or to components thereof.
12. Participants with cardiac arrhythmias that require immediate treatment.
13. Participants with a family history of long QT syndrome.
14. Participants on haemodialysis.
15. Participants with a history of bowel obstruction.
16. Participants with severe gastrointestinal disorder or major
gastrointestinal surgery (eg, large bowel resection).
17. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
18. Previous treatment with SZC.
19. Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry.
20. Previous enrolment in the present study.
21. Females who are pregnant, breastfeeding, or planning to become pregnant.
22. Judgment 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.
23. For the LTMP only: participants who are normokalaemic at Visit 8b and are receiving placebo at Visit 8a of the MP unless they received rescue treatment.
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method