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

Detailed criteria

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…

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)

Summary

Eligibility

Interventions

Locations (37)