NCT02694744

Patiromer With or Without Food for the Treatment of Hyperkalemia

The Effect of Food: An Open-Label, Randomized, Parallel Group Phase 4 Study of the Efficacy and Safety of Patiromer for Oral Suspension With or Without Food for the Treatment of Hyperkalemia (TOURMALINE)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Relypsa, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperkalemia

Interventions

Type	Name	Description
DRUG	patiromer	8.4 g/day starting dose, administered orally

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-07-01
• Completion: 2016-08-01
• First posted: 2016-02-29
• Last updated: 2021-05-12
• Results posted: 2017-11-20

Locations

29 sites across 1 country: United States

Regulatory

• FDA-regulated drug study