Patiromer Utility as an Adjunct Treatment in Patients Needing Urgent Hyperkalemia Management
(PLATINUM Trial)

Recruiting in Palo Alto (17 mi)

+18 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Comprehensive Research Associates

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion Criteria

Written informed consent obtained.

Hyperkalemia, defined as K+ ≥5.8 obtained via local laboratory or point-of-care testing

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

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

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Treatment Details

Interventions

Patiromer (Potassium Binder)
Placebo (Other)

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: VeltassaActive Control1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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