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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04443608
Recruitment Status : Recruiting
First Posted : June 23, 2020
Last Update Posted : May 27, 2022
Information provided by (Responsible Party):
Comprehensive Research Associates

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.

Condition or disease Intervention/treatment Phase
Hyperkalemia Drug: Patiromer Powder for Oral Suspension [Veltassa] Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, double-blinded, placebo-controlled parallel group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 8, 2020
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : November 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines Potassium
Drug Information available for: Patiromer

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 Name: 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 Name: Inactive substance

Primary Outcome Measures :
  1. The need for additional potassium-lowering medical interventions [ Time Frame: Duration of patient's emergency department visit, up to 10 hours ]
    Number of potassium-lowering therapeutic interventions administered after study drug

Secondary Outcome Measures :
  1. Potassium level trends after receiving study drug [ Time Frame: Up to 24 hours after study drug dose is given ]
    Potassium levels measured at hour 0, 2, 4, 6, 8, 10 and 24 hours after study drug administration

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04443608

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United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Rosen Mann    408-460-5885    rka@stanford.edu   
Principal Investigator: Youyou Duanmu, MD         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06519
Contact: Caitlin Malicki    203-737-6152    caitlin.malicki@yale.edu   
Principal Investigator: Basmah Safdar, MD         
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Abe Lovelace    313-745-6492    ef2030@wayne.edu   
Principal Investigator: Anthony Lagina, MD         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Hashem Nassereddine    313-404-9110    hnasser7@hfhs.org   
Principal Investigator: Howard Klausner, MD         
United States, Minnesota
Hennepin Healthcare Research Institute Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Audrey Hendrickson    612-873-9528    Audrey.Hendrickson@hcmed.org   
Principal Investigator: Brian Driver, MD         
United States, Missouri
Washington University of St Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jamie Mills    314-273-1382    jamiem@wustl.edu   
Principal Investigator: Douglas Char, MD         
United States, New York
Mt Sinai. Icahn School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Mitali Pradhan    201-423-3585    Mitali.Pradhan@mountsinai.org   
Principal Investigator: Jonathan Schimmel, MD         
Maimonides Medical Center Recruiting
New York, New York, United States, 11219
Contact: Rukhsana Hossain    718-283-6076    rhossain@maimonidesmed.org   
Stony Brook University Hospital Recruiting
Stony Brook, New York, United States, 11794
Contact: Rafael Fernandes    631-444-7857    Rafael.Fernandes@stonybrookmedicine.edu   
Principal Investigator: Adam Singer, MD         
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Lauren Kohler    336-716-4646    lekoehle@wakehealth.edu   
Principal Investigator: Jason Stopyra, MD         
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Jacqueline Davis    513-558-5359    davis2jq@ucmail.uc.edu   
Principal Investigator: Gregory Fermann, MD         
Ohio State University. Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Michael Hill    614-293-6185    Michael.hill@osumc.edu   
Principal Investigator: Jason Bischof, MD         
United States, Texas
JPS Health Network Recruiting
Fort Worth, Texas, United States, 76104
Contact: Max Masuda    817-702-6746    MMasuda@jpshealth.org   
Principal Investigator: James d'Etienne, MD         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Kelly Keene    713-873-7042    Kelly.Keene@bcm.edu   
Principal Investigator: Stephen Boone, MD         
UT Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Misty Ottman    713-500-7870    Misty.Ottman@uth.tmc.edu   
Principal Investigator: David Robinson, MD         
Sponsors and Collaborators
Comprehensive Research Associates
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Responsible Party: Comprehensive Research Associates
ClinicalTrials.gov Identifier: NCT04443608    
Other Study ID Numbers: CRA-US-001
First Posted: June 23, 2020    Key Record Dates
Last Update Posted: May 27, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Comprehensive Research Associates:
emergency department
Additional relevant MeSH terms:
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Water-Electrolyte Imbalance
Metabolic Diseases