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

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What is this study about?

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Spitalul Clinic De Urgenta Pentru Copii Cluj-Napoca	Cluj Napoca	Romania
Spitalul Clinic De Urgenta Pentru Copii Louis Turcanu Timisoara	Timisoara	Romania
Emergency Institute For Cardiovascular Diseases And Transplant	Targu Mures	Romania
Samodzielny Publiczny Dzieciecy Szpital Kliniczny Im. Jozefa Polikarpa Brudzinskiego W Warszawie	Warsaw	Poland
Fundeni Clinical Institute	Bucharest	Romania
Uhuqjwbaiecdbczaguzrp Ecvcn Aer	Essen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	26.11.2018
Poland	Recruiting	26.11.2018
Romania	Recruiting	26.11.2018
Spain	Recruiting	26.11.2018

Trial locations

Investigated drugs:

Sodium Zirconium Cyclosilicate

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.

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.

Trial ID:

2023-508455-38-00

Protocol code:

D9481C00001

NCT ID:

NCT03813407

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?