Actively Recruiting
Phase 2 Study of Patiromer to Treat High Potassium in Children Under 12 Years
Led by Vifor Pharma, Inc. · Updated on 2026-07-28
32
Participants Needed
37
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia. This phase 2 open-label study focuses on pediatric participants with elevated potassium levels to understand how patiromer may help manage this condition in young patients. The study involves a 4-week pharmacodynamic and dose-ranging period divided into three age cohorts 6 to less than 12 years, 2 to less than 6 years, and 0 to less than 2 years. Patiromer is administered once daily, with dose adjustments and splits depending on the participants age, especially in the youngest cohort. The study includes multiple assessments of potassium levels and safety monitoring during this period. Participants will undergo regular evaluations including potassium measurements, heart rate, blood pressure, body temperature, ECGs, and various laboratory tests for chemistry and hematology parameters. These assessments occur at baseline and multiple timepoints up to 28 days and may continue for up to 52 weeks in an extended part of the study. Safety monitoring includes tracking adverse events and changes in blood potassium and magnesium levels. The total participation duration may extend up to one year depending on study phase involvement.
CONDITIONS
Brief Title
Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age
Research Team
E
EMERALD-2 Clinical Study Team
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