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A Phase 3, Dose-Escalating Study in Children With Hyperkalaemia Between Birth and <18 Years of Age to Evaluate Increasing Doses of Sodium Zirconium Cyclosilicate (SZC) Given Three Times Daily for the Correction of Hyperkalaemia and the Effectiveness of the Same Dose of SZC Given Once Daily to Maintain Normokalaemia Among Those Requiring Continuous Treatment.

Low Urine Output

Potassium is an important mineral body needs to function correctly especially nerves, heart and muscles.
Potassium enters in body from the food we eat and from certain medicine. Our kidneys keep potassium at the correct level by flushing the excess out of our body into the urine. If our kidneys are not working properly the potassium level in the blood becomes too high. This is called hyperkalemia, or high potassium. Treatment is required to help body get rid of extra potassium in blood. Sodium zirconium cyclosilicate, SZC (LOKELMA™) is a medicine which is taken orally. It works by taking potassium from our stomach and intestines and removes it. This medicine is not absorbed and is eliminated via stool. This medicine has been shown to be effective and safe in adults through many studies.
The purpose of the study is to find out if this new medication called SZC will work and be safe for the treatment of hyperkalaemia in children under 18 years of age. SZC is approved medicine for adults. As such, the information gained from this study will help contribute to better treatments in the future for children living with hyperkalemia.

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Participation Requirements

  • Sex:

    Male, Female

  • Eligible Ages:

    0 to 17

Participation Criteria

Inclusion Criteria:
You or your child may be eligible to participate in this trial if you or your child:

- are between 0 and 17 years of age
- have been diagnosed with hyperkalaemia

Doctors will also evaluate other criteria to make sure you or your child qualify for the study.
Exclusion Criteria:
You or your child may not be eligible to participate in this trial if you or your child:

- have hyperkalaemia due to a secondary cause, such as dehydration, soft-tissue damage from crush injury/burns, excessive use of potassium supplements, or drug use
- have received sodium zirconium cyclosilicate treatment
- on dialysis requiring acute or chronic renal replacement therapy.
- history of bowel obstruction, severe gastrointestinal disorder or major gastrointestinal surgery

Doctors will also evaluate other criteria to make sure you or your child qualify for the study.

Study Location

University of Calgary
University of Calgary
Calgary, Alberta
Canada

Contact Study Team

Study Sponsored By
University of Calgary
Participants Required
More Information
Study ID: REB20-0852