Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age (NCT05766839) | Clinical Trial Compass
RecruitingPhase 2
Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age
United States32 participantsStarted 2025-04-06
Plain-language summary
A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia.
Who can participate
Age range0 Years – 11 Years
SexALL
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Inclusion Criteria:
* The following inclusion criteria must be met for each participant:
* \- Paediatric participants (\<12 years of age) with hyperkalaemia at screening.
* \- Participant's age should not reach 12 years during the 28 days of the pharmacodynamic/dose-ranging period.
* \- Participant is able to receive regular external feeding and medication, including via tubes, i.e., percutaneous endoscopic gastrostomy (PEG) or entero-gastric feeding tube.
* \- At screening/baseline, the results from 2 separate and consecutive potassium assessments using the same measurement method (whole blood, plasma, or serum) need to be above the age-appropriate upper limit of normal (ULN).
* \- If taking any renin-angiotensin aldosterone system inhibitors (RAASi), beta blockers, fludrocortisone, or diuretic medications, must be on a stable dose for at least 14 days prior to screening.
* \- Parent(s) or legally authorised representative(s) or another appropriate person delegated by the legally authorised representatives must be available to help the study-site personnel ensure follow-up; accompany the participant to the study site on each assessment day; accurately and reliably dispense investigational product as directed.
* \- Females of childbearing potential must be non-lactating, must have a negative pregnancy test at screening, and must have used an effective, acceptable form of contraception (e.g., abstinence) for at least 1 month before patiromer administration. Females of childbe…