Conditions: Hyperkalemia
Keywords: Treatment of Hyperkalemia Hyperkalemia Potassium Chronic Kidney Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 114
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of patiromer administered once daily (QD) when given with food compared to without food (experimental treatment group) for the treatment of hyperkalemia (high potassium in the blood).

Detailed description:
Approximately 110 eligible participants with hyperkalemia will be randomly assigned to receive a patiromer starting dose of 8.4- g/day, either with or without food.

All participants will undergo a screening period (1 day) to determine eligibility for study entry. Eligible participants will be treated for 4 weeks and followed for 2 weeks after completing the patiromer treatment. There are six planned clinic visits during the Treatment Period and two planned visits after the last dose of patiromer during the Follow-up Period.

The dose of patiromer may be increased or decreased (titrated) based on participants' individual potassium response.

Arms:
arm 1: Patiromer dosing without food arm 2: Patiromer dosing with food

Interventions: intervention 1: patiromer
Intervention descriptions: intervention 1: 8.4 g/day starting dose, administered orally

Protocol document: