Conditions: Hyperkalemia
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 6
Healthy volunteers: no

Brief summary:
This study assessed the pharmacodynamic effects of patiromer on serum potassium in participants on hemodialysis.

Detailed description:
The initial intent was to enroll 12-24 adult male and female participants on hemodialysis into the study. Due to significant recruitment challenges, the study was discontinued after six participants were enrolled in the study.

This was an open-label, multiple-dose, adaptive-design study in participants on hemodialysis. Eligible participants on hemodialysis were to remain in the Clinical Research Unit for 2 weeks (Day -7 to Day 8) and were required to consume a potassium, magnesium, calcium and sodium-controlled diet.

Arms:
arm 1: None

Interventions: intervention 1: patiromer
Intervention descriptions: intervention 1: 15 grams/day (5 grams 3 times daily) administered orally

Protocol document: