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

Hyperkalemia Clinical Trial

— PLATINUM  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04443608
• Other study ID #: CRA-US-001
• Status: Terminated
• Phase: Phase 4
• Start date: October 8, 2020
• Est. completion date: June 3, 2023

Study information

• Verified date: April 2023
• Source: Comprehensive Research Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 115
• Est. completion date: June 3, 2023
• Est. primary completion date: March 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperkalemia

Intervention

Drug:
• Patiromer Powder for Oral Suspension [Veltassa]
Powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink
• Placebo
Powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio
United States	Ohio State University. Wexner Medical Center	Columbus	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Wayne State University	Detroit	Michigan
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	University of Mississippi Medical Center	Jackson	Mississippi
United States	Hennepin Healthcare Research Institute	Minneapolis	Minnesota
United States	Yale University	New Haven	Connecticut
United States	Maimonides Medical Center	New York	New York
United States	Mt Sinai. Icahn School of Medicine	New York	New York
United States	Christiana Care	Newark	Delaware
United States	Washington University of St Louis	Saint Louis	Missouri
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Stanford University School of Medicine	Stanford	California
United States	Stony Brook University Hospital	Stony Brook	New York
United States	George Washington University	Washington	District of Columbia
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Comprehensive Research Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Potassium level trends after receiving study drug	Net clinical benefit at Hour 4	4 hours
Secondary	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
Secondary	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
Secondary	Potassium level trends after receiving study drug	K+ 24 hours after ED discharge	Up to 24 hours after study drug dose is given