Patiromer With or Without Food for the Treatment of Hyperkalemia (TOURMALINE)

Relypsa

Status and phase

Completed

Phase 4

Conditions

Hyperkalemia

Treatments

Drug: patiromer

Study type

Interventional

Funder types

Industry

Identifiers

NCT02694744

RLY5016-401

Details and patient eligibility

About

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).

Full 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.

Enrollment

114 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Potassium concentration > 5.0 mEq/L from two blood draws at Screening
Stable RAASi medication, if taking
Medications taken on a chronic basis are given once daily or twice daily
Informed consent given

Key Exclusion Criteria:

Expected need for dialysis
Major organ transplant
History of conditions associated with pseudohyperkalemia
History of swallowing disorder, gastroparesis, bariatric surgery, bowel obstruction or severe gastrointestinal disorders or major gastrointestinal surgery
Cancer or unstable medical condition