RecruitingPHASE3INTERVENTIONAL

An Open-label Study to Assess Safety and Efficacy of SZC in Paediatric Patients With Hyperkalaemia

This study is testing a medicine called Sodium Zirconium Cyclosilicate (SZC) in children under 18 who have a condition called hyperkalaemia (too much potassium in their blood). SZC has been shown to be helpful and safe for adults with this condition, so researchers expect it could also benefit children. The main goal is to find out if SZC is safe and works well to reduce high potassium levels and keep them normal in children. The study will involve about 140 children across various locations, including the UK, Europe, and North America. It will start with older children, and then, if safe, expand to younger age groups, including babies. The study has different phases to carefully check how the medicine works over time.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

140

Start

02 Apr 2019

Estimated completion

21 Feb 2030

Hyperkalaemia

What is this study about?

This research is looking into a medication called Sodium Zirconium Cyclosilicate (SZC) for children who have a health problem called hyperkalaemia. Hyperkalaemia means there's too much potassium in the blood, which can be serious if not managed. This medicine has already been found to be safe and effective for adults with hyperkalaemia, so scientists are hoping it will work just as well for younger patients.

The main aim of this study is to see if SZC can safely and effectively lower high potassium levels in children under 18, and then help keep those levels stable. Researchers will also look at how children tolerate the medicine. The study is particularly important because while we know a lot about how SZC works in adults, we need to understand if it's suitable and works in the right way for growing bodies. They will be looking at different doses to find the best and safest amount for children of various ages and sizes.

About 140 children will take part across many hospitals in different countries. The study will begin with older children and, if the independent experts agree it's safe, will gradually include younger children, even babies. By doing this research, doctors hope to find a better way to treat hyperkalaemia in children, which could improve their health and well-being. It is an 'open-label' study, which means everyone involved, including the participants and their doctors, will know that SZC is being given.

Key takeaways

This study evaluates a medicine called SZC for children with high potassium (hyperkalaemia).
SZC has been effective and safe for adults, and researchers hope it will benefit children.
The study aims to confirm if SZC is safe and effective in children under 18.
It will involve different age groups, starting with older children and possibly including babies later.
Participation involves taking the medicine and regular blood tests to monitor potassium levels.
You can withdraw your child from the study at any time without affecting their medical care.

Who may be eligible?

To join this study, a child needs to be under 18 years old. They must have hyperkalaemia, which means too much potassium in their blood. For children aged 2 years and older, this will usually be a long-term problem. For babies and very young children under 2, it could be a short-term or long-term issue.

The child's heart rhythm, checked with an ECG, must be within normal limits for their age. Also, they must be able to have blood samples taken regularly. If the participant is a girl who could become pregnant, she would need to have a negative pregnancy test before starting the medicine and use two types of contraception during the study, one of which must be a barrier method.

Most importantly, a parent or legal guardian will need to give written permission for their child to join the study. If the child is old enough to understand, they will also be asked if they agree to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child under 18 years old?
Does your child have hyperkalaemia (high potassium)?
Can your child have regular blood tests?
Is your child's heart rhythm normal (as checked by a doctor)?
If your child is a girl who could become pregnant, is she able and willing to use two forms of contraception during the study?

Answer every question to see your result.

What does participation involve?

If your child joins this study, they will take the study medicine, SZC. Initially, they'll take a dose three times a day for up to 3 days to bring their potassium levels down, which is called the 'Correction Phase'. After their potassium levels are normal, they will move to a 'Maintenance Phase' for 28 days, where they will take the medicine once a day. During this time, their doctor can adjust the dose to keep their potassium levels stable.

If their potassium levels remain good, they might have the option to continue in a 'Long-Term Maintenance Phase' to keep taking the medicine. Throughout the study, your child will have regular blood tests to check their potassium levels and other important health markers. The total number of clinic visits and the exact duration of your child's participation will depend on how they respond to the treatment and whether they continue into the long-term phase.

Potential risks and benefits

Potential benefits of participating in this study include gaining access to a new treatment for hyperkalaemia that has shown promise in adults. If successful, this medicine could help manage your child's potassium levels, which is important for their overall health. As with any medicine, there are potential risks, such as side effects, though the study aims to carefully monitor your child's health throughout. There's also the chance that the medicine may not work for your child. All participants are free to leave the study at any time, for any reason, without it affecting their usual medical care.

Locations (70)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Research Site
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Birmingham, United States· Recruiting
Research Site
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Atlanta, United States· Withdrawn
Research Site
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Baltimore, United States· Recruiting
Research Site
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Grand Rapids, United States· Withdrawn
Research Site
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St Louis, United States· Withdrawn
Research Site
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Hackensack, United States· Completed
Research Site
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New York, United States· Withdrawn
Research Site
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Stony Brook, United States· Withdrawn
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Charlotte, United States· Withdrawn
Research Site
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Winston-Salem, United States· Withdrawn
Research Site
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Akron, United States· Completed
Research Site
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Cincinnati, United States· Recruiting

Common questions

What is hyperkalaemia?

Hyperkalaemia means your child has too much potassium in their blood, which can be harmful if not treated.

What is SZC?

SZC is a medicine that helps lower high potassium levels in the blood. It's already used for adults, and this study looks at it for children.

Will my child know if they are getting the real medicine?

Yes, this is an 'open-label' study, meaning everyone involved, including you and your child's doctors, will know that SZC is being given.

How long will my child be in the study?

The study has different phases, starting with up to 3 days, then 28 days, and potentially a longer-term option. Your child's doctor can give you more details.

Can we stop participating if we change our mind?

Yes, you are free to withdraw your child from the study at any time, for any reason, without it affecting their usual medical care.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.