BridgeMD
An open-label study to assess safety and efficacy of SZC in paediatric patients with hyperkalaemia
EU CTIS ID: 2023-508455-38-00
What this study is testing
Correction phase (CP) primary objective: To evaluate the ability to achieve normokalaemia during the CP when initiating treatment with SZC of different dose levels (DLs) in children with hyperkalaemia 28-day Maintenance Phase (MP) primary objective: To evaluate the ability to maintain normokalaemia during the MP when continuing SZC treatment in children achieving normokalaemia
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 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.
- 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: <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.
- Ability to have repeated blood draws or effective venous catheterisation.
You likely can't join if
- Neonates with a gestational age <37 weeks at birth or a birth weight <2500 g.
- Participants who are known to have tested Human Immunodeficiency Virus (HIV) positive.
- 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.
- Known hypersensitivity or previous anaphylaxis to SZC or to components thereof.
- Participants with cardiac arrhythmias that require immediate treatment.
- Participants with a family history of long QT syndrome.
See the full eligibility criteria
Who can join
- 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 requiring either short- or long-term treatment for hyperkalaemia (acute and chronic hyperkalaemia) in the age cohort <2 years.
- 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: <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.
- 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 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.
- 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.
What rules you out
- Neonates with a gestational age <37 weeks at birth or a birth weight <2500 g.
- Participants who are known to have tested Human Immunodeficiency Virus (HIV) positive.
- 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.
- Known hypersensitivity or previous anaphylaxis to SZC or to components thereof.
- Participants with cardiac arrhythmias that require immediate treatment.
- Participants with a family history of long QT syndrome.
- Participants on haemodialysis.
- Participants with a history of bowel obstruction.
- Participants with severe gastrointestinal disorder or major gastrointestinal surgery (eg, large bowel resection).
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Previous treatment with SZC.
- Term and preterm neonates with suspected conditions predisposing them to intestinal ischaemia (eg, perinatal hypoxia or sepsis).
- 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.
- Previous enrolment in the present study.
- Females who are pregnant, breastfeeding, or planning to become pregnant.
- 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.
- 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.
- 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.
- 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)
- Participants with transient iatrogenic hyperkalaemia (eg. due to treatment with tacrolimus).
- Participants treated with lactulose, rifaximin (XIFAXAN™), or other nonabsorbed antibiotics for hyperammonaemia within the last 7 days.
- Participants treated with CPS, sodium polystyrene sulfonate (eg, KAYEXALATE™), or patiromer within the last 4 days prior to first dose of study treatment.
- Participants with a life expectancy of less than 3 months.
The study team makes the final eligibility decision.
Where it's taking place
- India
- United States
- Brazil
- China
- Canada
- Ukraine
- United Kingdom
- Japan
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include India; United States; Brazil; China; Canada; Ukraine and 2 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 EU CTIS; the study team decides eligibility.