SODIUM ZIRCONIUM CYCLOSILICATE for Hyperkalaemia

Inclusion criteria

• {"criterion_text":"- Provision of written informed consent of the participant or legal representative, and informed assent from the participant (as appropriate)\n- Female or male from birth to <18 years of age (for the study duration)\n- 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.\n- Participants must meet the following criteria for hyperkalaemia: Please refer to the Table 6 in the protocol.\n- 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.\n- Ability to have repeated blood draws or effective venous catheterisation.\n- 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.\n- Optional, LTMP only: a. 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. b. Participants who are normokalaemic at the end of MP or hyperkalaemic and not on maximum dose. c. Participants who would benefit from long-term treatment for their hyperkalaemia, as judged by the Investigator."}

Exclusion criteria

• {"criterion_text":"- Neonates with a gestational age <37 weeks at birth or a birth weight <2500 g.\n- Term and preterm neonates with suspected conditions predisposing them to intestinal ischaemia (eg, perinatal hypoxia or sepsis).\n- Participants with pseudohyperkalaemia caused by excessive fist clenching to enable venepuncture, by haemolysed blood specimens, or by severe leukocytosis or thrombocytosis.\n- Participants with hyperkalaemia due to soft-tissue damage from crush injury or burns.\n- 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)\n- Participants with transient iatrogenic hyperkalaemia (eg. due to treatment with tacrolimus).\n- Participants treated with lactulose, rifaximin (XIFAXAN™), or other nonabsorbed antibiotics for hyperammonaemia within the last 7 days.\n- Participants treated with CPS, sodium polystyrene sulfonate (eg, KAYEXALATE™), or patiromer within the last 4 days prior to first dose of study treatment.\n- Participants with a life expectancy of less than 3 months.\n- Participants who are known to have tested Human Immunodeficiency Virus (HIV) positive.\n- Participants with a family history of long QT syndrome.\n- 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.\n- Previous enrolment in the present study.\n- Participants with cardiac arrhythmias that require immediate treatment.\n- 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.\n- Known hypersensitivity or previous anaphylaxis to SZC or to components thereof.\n- Participants on haemodialysis.\n- Participants with a history of bowel obstruction.\n- Participants with severe gastrointestinal disorder or major gastrointestinal surgery (eg, large bowel resection).\n- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).\n- Previous treatment with SZC.\n- 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.\n- 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."}

Primary endpoints

• {"endpoint_text":"- CP primary endpoint: Normokalaemia achieved in the CP within 3 days (yes/no)","definition_or_measurement_approach":"Correction Phase (CP): achievement of normokalaemia within 3 days after initiating SZC; measured as serum potassium (S-K+) with a binary outcome (yes/no) within 3 days."}
• {"endpoint_text":"- 28-day MP primary endpoint:Serum potassium (S-K+) value within normokalaemia range (yes/no) at each of the last two scheduled visits in the MP","definition_or_measurement_approach":"28-day Maintenance Phase (MP): S-K+ value within normokalaemia range (yes/no) at each of the last two scheduled MP visits; measured by serum potassium at scheduled visits."}

Secondary endpoints

• {"endpoint_text":"- All phases secondary endpoint: S-K+ level at each scheduled visit","definition_or_measurement_approach":"Serum potassium (S-K+) concentration measured at each scheduled visit across all phases."}
• {"endpoint_text":"- MP secondary endpoints: Change in serum aldosterone levels from baseline to Week 3 of the MP Change in serum electrolytes (including bicarbonate), and spot urinary pH and urinary electrolytes from baseline to week 3 of the MP","definition_or_measurement_approach":"Change from baseline to Week 3 of MP in serum aldosterone, serum electrolytes (including bicarbonate), spot urinary pH and urinary electrolytes; measured by laboratory assays at baseline and Week 3."}
• {"endpoint_text":"- LTMP secondary endpoints: S-K+ value within normokalaemia range (yes/no) at each scheduled visit in the LTMP","definition_or_measurement_approach":"Long-term Maintenance Phase (LTMP): S-K+ within normokalaemia range (yes/no) at each scheduled LTMP visit; measured by serum potassium at scheduled visits."}

Spain

Earliest CTIS Part Ii Submission Date

18-03-2024

Latest Decision Or Authorization Date

21-01-2025

Processing Time Days

309

Number Of Sites

2

Number Of Participants

24

Romania

Earliest CTIS Part Ii Submission Date

18-03-2024

Latest Decision Or Authorization Date

31-03-2025

Processing Time Days

378

Number Of Sites

4

Number Of Participants

9

Germany

Earliest CTIS Part Ii Submission Date

18-03-2024

Latest Decision Or Authorization Date

12-05-2026

Processing Time Days

785

Number Of Sites

2

Number Of Participants

9

Poland

Earliest CTIS Part Ii Submission Date

18-03-2024

Latest Decision Or Authorization Date

15-05-2026

Processing Time Days

788

Number Of Sites

1

Number Of Participants

16

Primary sponsor

Full Name

AstraZeneca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden

Contract research organisations

Name

Fortrea Development Limited

Responsibilities

Codes: 1,10,11,12,2,5,6,7,8,9 (as listed in sponsor duties)

Third parties

• {"country":"United States","full_name":"Welocalize Inc.","duties_or_roles":"Translations","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Calyx","duties_or_roles":"3","organisation_type":"Industry"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Center For Information And Study On Clinical Research Participation Inc.","duties_or_roles":"Thank you communication, on-going post trial communication, Lay language trial results summary","organisation_type":"Patient organisation/association"}
• {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Questionnaire translation","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"clinical chemistry, clinical haematology","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Emsere B.V.","duties_or_roles":"provision of thermometers","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Fortrea Development Limited","duties_or_roles":"1,10,11,12,2,5,6,7,8,9","organisation_type":"Pharmaceutical company"}