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Study on the Safety and Effectiveness of Sodium Zirconium Cyclosilicate for Children with High Potassium Levels

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the condition known as hyperkalemia, which is characterized by high levels of potassium in the blood. The treatment being tested in this study is called Sodium Zirconium Cyclosilicate, also known by its code name SZC. This medication is provided in the form of an oral suspension, which means it is a liquid that is taken by mouth. The purpose of the study is to evaluate the safety and effectiveness of SZC in children who have hyperkalemia.

The study is divided into different phases. Initially, there is a Correction Phase where the main goal is to see if SZC can help achieve normal potassium levels in the blood, known as normokalemia, within a few days. Following this, there is a 28-day Maintenance Phase where the focus is on maintaining these normal potassium levels in children who have already achieved them. Throughout the study, participants will take SZC and have regular check-ups to monitor their potassium levels and overall health.

Participants in the study will be children from birth up to 18 years old who need treatment for hyperkalemia. The study will involve regular visits to monitor the levels of potassium and other substances in the blood. The treatment period can last up to 26 weeks, depending on the needs of the participants. The study aims to provide valuable information on how well SZC works in managing hyperkalemia in children and its safety profile over time.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant or their legal representative must provide written informed consent. If appropriate, the participant will also provide informed assent.
Participants are children from birth to under 18 years of age who require treatment for high potassium levels, known as hyperkalaemia.
Step 2
Correction phase (CP)
The primary goal of this phase is to achieve normal potassium levels, referred to as normokalaemia, within 3 days.
Participants will begin treatment with sodium zirconium cyclosilicate (SZC), also known as AZD7270 or Lokelma, in the form of a 5 g powder for oral suspension.
The medication is taken orally, and the dosage will vary depending on the participant's needs.
Step 3
Maintenance phase (MP)
This phase lasts for 28 days and aims to maintain normal potassium levels in participants who achieved normokalaemia during the correction phase.
Participants will continue taking SZC as prescribed.
Regular monitoring of serum potassium levels will occur at each of the last two scheduled visits.
Step 4
Long-term maintenance phase (LTMP)
Participation in this phase is optional and requires additional consent.
It is intended for participants who are either normokalaemic at the end of the maintenance phase or hyperkalaemic but not on the maximum dose.
The goal is to provide long-term treatment for hyperkalaemia, as determined by the investigator.

Who can join the trial?

8 criteria

Written informed consent must be provided by the participant or their legal representative. If appropriate, the participant should also give their agreement to participate.
The participant can be a girl or boy from birth up to less than 18 years old during the study.
Participants aged 2 years and older must need long-term treatment for **hyperkalaemia** (a condition where there is too much potassium in the blood). Participants younger than 2 years can need either short-term or long-term treatment for hyperkalaemia.
Participants must meet specific criteria for hyperkalaemia as detailed in the study protocol.
A digital **ECG** (a test that records the heart's electrical activity) must show that the **QT interval** (a measure of heart rhythm) is within age-appropriate limits at the start of the study. The QT interval is adjusted for heart rate using **Bazett's method**. If there is a difference between automatic and manual ECG measurements, the manual measurement is considered correct.
The participant must be able to have repeated blood tests or have a reliable way to access their veins for blood sampling.
Females who can become pregnant must have a negative pregnancy test within one day before starting the study medication. If they are sexually active, they must use two forms of medically approved birth control, with at least one being a barrier method (like a condom).
For the optional long-term maintenance phase, participants must provide written informed consent and assent if appropriate. They should be either normokalaemic (normal potassium levels) at the end of the maintenance phase or hyperkalaemic but not on the maximum dose. They should also be judged by the investigator to benefit from long-term treatment for hyperkalaemia.

Who cannot join the trial?

4 criteria

Patients who have a medical condition called hyperkalaemia, which means having too much potassium in the blood, cannot participate.
Children who are not within the specified age range for the study cannot participate.
Patients who do not meet the health requirements set by the study cannot participate.
Patients who are part of a vulnerable population, meaning they may need special protection or care, cannot participate.

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Verified sites

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Hospital Sant Joan De Deu Barcelona
Esplugues De Llobregat, Spain
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Hospital Universitario 12 De Octubre
Madrid, Spain
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Spitalul Clinic De Urgenta Pentru Copii Louis Turcanu Timisoara
Timisoara, Romania

Trial locations

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Investigated drugs

SZC is a medication being studied for its ability to help children with hyperkalaemia, which is a condition where there is too much potassium in the blood. The study aims to see if SZC can help bring potassium levels back to normal and keep them there over time.

Sodium Zirconium Cyclosilicate

What is already known about the treatment

Sodium Zirconium Cyclosilicate (SZC) – This medication is administered orally, typically in the form of a powder that is mixed with water. It is currently being studied in clinical trials for its safety and effectiveness in treating hyperkalaemia, particularly in pediatric patients. The main therapeutic indication for SZC is to manage high potassium levels in the blood. At the molecular level, SZC works by exchanging sodium ions for potassium ions in the gastrointestinal tract, thereby reducing potassium levels in the bloodstream. It is classified as a potassium binder in pharmacology.

Investigated diseases

Hyperkalemia – Hyperkalemia is a condition characterized by an abnormally high level of potassium in the blood. Potassium is an essential mineral that helps regulate nerve and muscle function, including the heart. When potassium levels are too high, it can disrupt normal electrical activity in the heart, potentially leading to irregular heartbeats. The condition can develop due to various factors, such as kidney dysfunction, certain medications, or excessive potassium intake. Symptoms may include muscle weakness, fatigue, and palpitations, although some individuals may not experience noticeable symptoms. Monitoring and managing potassium levels are crucial to prevent complications associated with hyperkalemia.