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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
1 other identifier
interventional
115
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2020
Typical duration for phase_4
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2020
CompletedFirst Posted
Study publicly available on registry
June 23, 2020
CompletedStudy Start
First participant enrolled
October 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2023
CompletedAugust 31, 2023
April 1, 2023
2.4 years
June 8, 2020
August 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Potassium level trends after receiving study drug
Up to 24 hours after study drug dose is given
Potassium level trends after receiving study drug
4 hours
Potassium level trends after receiving study drug
ED visit, up to 10 hours
Potassium level trends after receiving study drug
8 hours
Potassium level trends after receiving study drug
Up to 24 hours after study drug dose is given
Study Arms (2)
Veltassa
ACTIVE COMPARATOR3 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
Placebo
PLACEBO COMPARATOR3 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
Interventions
Powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink
Powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Stanford University School of Medicine
Stanford, California, 94305, United States
Yale University
New Haven, Connecticut, 06519, United States
Christiana Care
Newark, Delaware, 19718, United States
George Washington University
Washington D.C., District of Columbia, 20037, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Wayne State University
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, 55415, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Washington University of St Louis
St Louis, Missouri, 63110, United States
Mt Sinai. Icahn School of Medicine
New York, New York, 10029, United States
Maimonides Medical Center
New York, New York, 11219, United States
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
Ohio State University. Wexner Medical Center
Columbus, Ohio, 43210, United States
JPS Health Network
Fort Worth, Texas, 76104, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
UT Memorial Hermann Hospital
Houston, Texas, 77030, United States
Related Publications (1)
Rafique Z, Budden J, Quinn CM, Duanmu Y, Safdar B, Bischof JJ, Driver BE, Herzog CA, Weir MR, Singer AJ, Boone S, Soto-Ruiz KM, Peacock WF. Patiromer utility as an adjunct treatment in patients needing urgent hyperkalaemia management (PLATINUM): design of a multicentre, randomised, double-blind, placebo-controlled, parallel-group study. BMJ Open. 2023 Jun 12;13(6):e071311. doi: 10.1136/bmjopen-2022-071311.
PMID: 37308268DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2020
First Posted
June 23, 2020
Study Start
October 8, 2020
Primary Completion
March 9, 2023
Study Completion
June 3, 2023
Last Updated
August 31, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share