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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Hyperkalemia

In brief

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.

Key facts

Study ID

NCT04443608

Run by

Comprehensive Research Associates

People needed

115

Starts

2020-10-08

Expected to finish

2023-06-03

Last updated by the study team

2023-08-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Hyperkalemia, defined as K+ ≥5.8 obtained via local laboratory or point-of-care testing
• Written informed consent obtained.

You may not qualify if…

• 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

Where it is running

• Stanford University School of Medicine — Stanford, California, United States
• Yale University — New Haven, Connecticut, United States
• Christiana Care — Newark, Delaware, United States
• George Washington University — Washington D.C., District of Columbia, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Wayne State University — Detroit, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Hennepin Healthcare Research Institute — Minneapolis, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Washington University of St Louis — St Louis, Missouri, United States
• Mt Sinai. Icahn School of Medicine — New York, New York, United States
• Maimonides Medical Center — New York, New York, United States
• Stony Brook University Hospital — Stony Brook, New York, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Ohio State University. Wexner Medical Center — Columbus, Ohio, United States
• JPS Health Network — Fort Worth, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• UT Memorial Hermann Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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