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
Summary
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.
Eligibility
Eligible gender: Male, Female
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.
Participate
Fill out the following form if you want to participate in this research
Collection of personal information
Your personal information is collected under
the authority of section 33(c) of the Freedom of Information and Protection of Privacy Act. If
you have any questions about the collection or use of this information, please visit our
Access to Information page.
Additional information
Contact information
Please contact our study coordinator Laurel Ryan at 403-383-0339 or Laurel.Ryan@albertahealthservices.ca if you would like to learn more about this trial.
Principal investigator:
Silviu Grisaru
Clinical trial:
Yes
REB-ID:
REB20-0852