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)
Vifor Pharma, Inc.
Summary
A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia.
Eligibility
- Age range
- 0–11 years
- Sex
- All
- Healthy volunteers
- No
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 blo…
Interventions
- DrugPatiromer
Patiromer will be given once daily; In Cohort 3, depending on the dose and the study participant's age, the total daily dose might be split
Locations (37)
- Children's Hospital ColoradoAurora, Colorado
- UF Health Pediatric Multispecialty Center SiteJacksonville, Florida
- Miller School of Medicine, University of MiamiMiami, Florida
- Arnold Palmer Hospital for ChildrenOrlando, Florida
- Augusta University - Children's Hospital of GeorgiaAugusta, Georgia
- University of Illinois College of MedicinePeoria, Illinois