A 2-Part, Open-Label, Phase 2, Multiple Dose Study to Evaluate the Pharmacodynamic Effects, Safety, and Tolerability of Patiromer in Children under 12 Years of Age with Hyperkalaemia (EMERALD2)
A 2-Part, Open-Label, Phase 2, Multiple Dose Study to Evaluate the Pharmacodynamic Effects, Safety, and Tolerability of Patiromer in Children under 12 Years of Age with Hyperkalaemia (EMERALD2)
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Clinical Trial Information
Trial Contact: Bobe Cortes, Estefania; Kube, Alicia; Modi, Bhavya
Trial Phone: 321.842.4773 ; 321.841.7485 ; 8573904886
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IRB No: W24.180.11
Protocol Abbrev: EMERALD2
Principal Investigator: Jeffery Alan Johnson, MD
Phase: Drug: Phase II
Age Group: Pediatric; Neonate
Secondary Protocol No: RLY5016-208p
ClinicalTrials.gov ID: NCT05766839
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Objective
Primary Objective:
• To assess change in potassium levels from baseline to Day 28 following administration of different doses of patiromer administered in children 0 to <12 years of age with hyperkalaemia.
Secondary Objective:
• To assess the safety and tolerability of patiromer in children 0 to <12 years of age with hyperkalaemia.
