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

Primary Purpose

Hyperkalemia

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Patiromer Powder for Oral Suspension [Veltassa]
Placebo
Sponsored by
Comprehensive Research Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperkalemia focused on measuring potassium, dialysis, emergency department

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University School of Medicine
  • Yale University
  • Christiana Care
  • George Washington University
  • Baystate Medical Center
  • Wayne State University
  • Henry Ford Hospital
  • Hennepin Healthcare Research Institute
  • University of Mississippi Medical Center
  • Washington University of St Louis
  • Mt Sinai. Icahn School of Medicine
  • Maimonides Medical Center
  • Stony Brook University Hospital
  • Wake Forest University Health Sciences
  • University of Cincinnati
  • Ohio State University. Wexner Medical Center
  • JPS Health Network
  • Baylor College of Medicine
  • UT Memorial Hermann Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Veltassa

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

The need for additional potassium-lowering medical interventions
Net clinical benefit (mean difference in number of interventions less change in serum potassium)

Secondary Outcome Measures

Potassium level trends after receiving study drug
Proportion of subjects without post-baseline potassium-related medical interventions at Hours 4, 6 and 8
Potassium level trends after receiving study drug
Net clinical benefit at Hour 4
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
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
Potassium level trends after receiving study drug
K+ 24 hours after ED discharge

Full Information

First Posted
June 8, 2020
Last Updated
August 29, 2023
Sponsor
Comprehensive Research Associates
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1. Study Identification

Unique Protocol Identification Number
NCT04443608
Brief Title
Patiromer Utility as an Adjunct Treatment in Patients Needing Urgent Hyperkalemia Management
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Recruitment window ended
Study Start Date
October 8, 2020 (Actual)
Primary Completion Date
March 9, 2023 (Actual)
Study Completion Date
June 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Comprehensive Research Associates

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperkalemia
Keywords
potassium, dialysis, emergency department

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
randomized, double-blinded, placebo-controlled parallel group
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Veltassa
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Patiromer Powder for Oral Suspension [Veltassa]
Other Intervention Name(s)
Active drug
Intervention Description
Powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Inactive substance
Intervention Description
Powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink
Primary Outcome Measure Information:
Title
The need for additional potassium-lowering medical interventions
Description
Net clinical benefit (mean difference in number of interventions less change in serum potassium)
Time Frame
Duration of patient's emergency department visit, up to 6 hours
Secondary Outcome Measure Information:
Title
Potassium level trends after receiving study drug
Description
Proportion of subjects without post-baseline potassium-related medical interventions at Hours 4, 6 and 8
Time Frame
Up to 24 hours after study drug dose is given
Title
Potassium level trends after receiving study drug
Description
Net clinical benefit at Hour 4
Time Frame
4 hours
Title
Potassium level trends after receiving study drug
Description
Number of post-baseline potassium-related medical interventions up until Hours 4, 6, and 8 and ED discharge
Time Frame
ED visit, up to 10 hours
Title
Potassium level trends after receiving study drug
Description
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
Time Frame
8 hours
Title
Potassium level trends after receiving study drug
Description
K+ 24 hours after ED discharge
Time Frame
Up to 24 hours after study drug dose is given

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Christiana Care
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Hennepin Healthcare Research Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Washington University of St Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mt Sinai. Icahn School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Maimonides Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ohio State University. Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
JPS Health Network
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
UT Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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