Patiromer Utility as an Adjunct Treatment in Patients Needing Urgent Hyperkalemia Management

Study Overview
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Brief Summary
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When a patient arrives to an emergency department and is found to have an elevated potassium level in the blood, there is no one standardized treatment, therefore it is not known if one treatment is superior to other. The purpose of this study is to help determine if a drug called patiromer (already approved by the FDA) can help lower potassium levels while patients are in the emergency department.

Detailed Description
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Given the lack of consistency in hyperkalemia treatment in the ED and the high cost of emergent dialysis, there is a need for the development and systematic evaluation of a treatment protocol to shift potassium into the cells followed by the removal of potassium from the body with a potassium binder.. The present study will use a systematic approach to shifting potassium into the cells followed by binding potassium in the gastrointestinal tract in hyperkalemic patients presenting to the ED. Study subjects will receive patiromer or placebo to determine if patiromer reduces the need for additional medical intervention for the management of hyperkalemia in patients initially treated with IV and inhaled therapy in the ED. Upon enrollment, patiromer will be administered at a dose selected because of its safety and efficacy shown in a pilot study named REDUCE. Up to 300 patients will be enrolled and followed for up to 14 days, and potassium levels will be measured at pre-determined intervals to assess drug's impact. concomitant medications will be recorded to help determine if study drug helped, not just lower hyperkalemia, but also decrease the number of total interventions needed to reach a normal potassium level.

Official Title
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A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase 4 Study of the Efficacy & Safety of Patiromer for Oral Suspension in Combination With Standard of Care Treatment in ED Patients With Hyperkalemia

Conditions
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Hyperkalemia

Intervention / Treatment
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* Drug: Patiromer Powder for Oral Suspension [Veltassa]
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hyperkalemia, defined as K+ ≥5.8 obtained via local laboratory or point-of-care testing Written informed consent obtained. Exclusion Criteria: Clinically significant arrhythmia, defined as any arrhythmia requiring ongoing IV antiarrhythmic therapy. Patients who are hemodynamically unstable, defined as mean arterial pressure ≤65 mmHg or heart rate ≤40 beats per minute or ≥125 beats per minute at time of screening Hyperkalemia solely due to overdose on potassium supplements Known bowel obstruction Subjects currently being treated with or having taken potassium binders (e.g., patiromer, sodium or calcium polystyrene sulfonate or sodium zirconium cyclosilicate) in the 7 days prior to baseline Subjects expected to receive dialysis during the first 6 hours of the study treatment period Known hypersensitivity to patiromer or its ingredients Participation in any other investigational device or drug study <30 days prior to screening, or current treatment with other investigational agent(s) Inability to consume the investigational product or, in the opinion of the Investigator unsuitable for study participation Life expectancy of less than 6 months Patients with automatically timed medication orders to control potassium in the ED Patient is known to be pregnant or breastfeeding An employee of investigational site or sponsors

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
Interventional Model Description: randomized, double-blinded, placebo-controlled parallel group
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Veltassa<br>3 packets of study drug powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink while in the emergency department | Drug: Patiromer Powder for Oral Suspension [Veltassa]<br>* Powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink<br>* Other names: Active drug;|
| Placebo Comparator: Placebo<br>3 packets of study drug powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink while in the emergency department | Drug: Placebo<br>* Powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink<br>* Other names: Inactive substance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The need for additional potassium-lowering medical interventions | Net clinical benefit (mean difference in number of interventions less change in serum potassium) | Duration of patient's emergency department visit, up to 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Potassium level trends after receiving study drug | Proportion of subjects without post-baseline potassium-related medical interventions at Hours 4, 6 and 8 | Up to 24 hours after study drug dose is given | 
| Potassium level trends after receiving study drug | Net clinical benefit at Hour 4 | 4 hours | 
| Potassium level trends after receiving study drug | Number of post-baseline potassium-related medical interventions up until Hours 4, 6, and 8 and ED discharge | ED visit, up to 10 hours | 
| Potassium level trends after receiving study drug | Proportion of subjects with sustained potassium reduction (defined as K+ ≤5.5 mEq/l and 4 hours without potassium-related medical intervention) at Hours 6 and 8 | 8 hours | 
| Potassium level trends after receiving study drug | K+ 24 hours after ED discharge | Up to 24 hours after study drug dose is given | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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potassium, dialysis, emergency department