A 2-Part, Open-Label, Phase 2 Study Evaluating the Pharmacodynamic Effects, Safety, and Tolerability of Patiromer in Children Under 12 Years With Hyperkalaemia

What this Trial Is About

Researchers are evaluating the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years old with hyperkalaemia, a condition involving high potassium levels in the blood. This Phase 2, open-label study aims to better understand how patiromer works in this young population and to monitor any side effects or safety concerns. The study involves a 4-week pharmacodynamic and dose-ranging period divided into three age cohorts: children aged 6 to less than 12 years, 2 to less than 6 years, and 0 to less than 2 years. In the youngest cohort, participants are further grouped into those aged 0 to less than 6 months and 6 to less than 24 months. Patiromer will be given once daily, with dosing adjusted by age, and for the youngest participants, the daily dose might be split. During the study, participants will have regular potassium level assessments and various laboratory tests, including chemistry and hematology evaluations, as well as monitoring of heart rate, blood pressure, body temperature, and ECG readings. Researchers will track any treatment-emergent or serious adverse events up to 54 weeks in an extended part of the study. The primary measurement is the change in potassium levels from baseline to Day 28. Follow-up and safety evaluations continue throughout the study duration, which may last up to 52 weeks for some assessments.

Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age