Patiromer With or Without Food for the Treatment of Hyperkalemia

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Hyperkalemia

Intervention / Treatment
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* Drug: patiromer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 - Dosing Without Food<br>Patiromer dosing without food | Drug: patiromer<br>* 8.4 g/day starting dose, administered orally<br>* Other names: RLY5016 for Oral Suspension;|
| Active Comparator: Group 2 - Dosing With Food<br>Patiromer dosing with food | Drug: patiromer<br>* 8.4 g/day starting dose, administered orally<br>* Other names: RLY5016 for Oral Suspension;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4 |  | 21 to 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Serum Potassium From Baseline to Week 4 | An ANCOVA model was used to estimate the mean serum potassium change from Baseline to Week 4 with baseline serum potassium as a covariate and treatment group, race (white vs all others), and history of Type 1 or 2 diabetes mellitus (yes or no) as factors in the model. | Baseline to Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment of Hyperkalemia, Hyperkalemia, Potassium, Chronic Kidney Disease