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

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

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.

Study Overview

• Status: Terminated
• Conditions: Hyperkalemia
• Intervention / Treatment: Drug: Patiromer Powder for Oral Suspension [Veltassa]; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale University
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48201
      • Wayne State University
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin Healthcare Research Institute
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University of St Louis
  • New York
    • New York, New York, United States, 11219
      • Maimonides Medical Center
    • New York, New York, United States, 10029
      • Mt Sinai. Icahn School of Medicine
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Hospital
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati
    • Columbus, Ohio, United States, 43210
      • Ohio State University. Wexner Medical Center
  • Texas
    • Fort Worth, Texas, United States, 76104
      • JPS Health Network
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77030
      • UT Memorial Hermann Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Veltassa; 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]; Powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink; Other Names: Active drug
Placebo Comparator: Placebo; 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; Powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink; Other Names: Inactive substance

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Comprehensive Research Associates

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2020
• Primary Completion (Actual): March 9, 2023
• Study Completion (Actual): June 3, 2023

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: dialysis; emergency department; potassium
• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyperkalemia
• Other Study ID Numbers: CRA-US-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes