Clinical trial NCT04443608: Patiromer Utility as an Adjunct Treatment in Patients Needing Urgent Hyperkalemia Management
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hyperkalemia
Keywords: potassium
dialysis
emergency department
Lead sponsor: Comprehensive Research Associates
Sponsor class: INDUSTRY
First posted: 2020-06-23
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double-blinded, placebo-controlled parallel group
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Clinically significant arrhythmia, defined as any arrhythmia requiring ongoing IV antiarrhythmic therapy.
2. 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
3. Hyperkalemia solely due to overdose on potassium supplements
4. Known bowel obstruction
5. 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
6. Subjects expected to receive dialysis during the first 6 hours of the study treatment period
7. Known hypersensitivity to patiromer or its ingredients
8. Participation in any other investigational device or drug study \<30 days prior to screening, or current treatment with other investigational agent(s)
9. Inability to consume the investigational product or, in the opinion of the Investigator unsuitable for study participation
10. Life expectancy of less than 6 months
11. Patients with automatically timed medication orders to control potassium in the ED
12. Patient is known to be pregnant or breastfeeding
13. An employee of investigational site or sponsors

Primary outcomes:
measure: The need for additional potassium-lowering medical interventions
timeFrame: Duration of patient's emergency department visit, up to 6 hours
Secondary outcomes:
measure: Potassium level trends after receiving study drug
timeFrame: Up to 24 hours after study drug dose is given
measure: Potassium level trends after receiving study drug
timeFrame: 4 hours
measure: Potassium level trends after receiving study drug
timeFrame: ED visit, up to 10 hours
measure: Potassium level trends after receiving study drug
timeFrame: 8 hours
measure: Potassium level trends after receiving study drug
timeFrame: Up to 24 hours after study drug dose is given
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Newark
country: United States
facility: Christiana Care
state: Delaware
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin Healthcare Research Institute
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University of St Louis
state: Missouri
city: New York
country: United States
facility: Mt Sinai. Icahn School of Medicine
state: New York
city: New York
country: United States
facility: Maimonides Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Ohio State University. Wexner Medical Center
state: Ohio
city: Fort Worth
country: United States
facility: JPS Health Network
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: UT Memorial Hermann Hospital
state: Texas
Study officials:
References: