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

• ClinicalTrials.gov Identifier: NCT04443608
• Recruitment Status: Recruiting
• First Posted: June 23, 2020
• Last Update Posted: May 27, 2022
• Sponsor: Comprehensive Research Associates
• Information provided by (Responsible Party): Comprehensive Research Associates

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

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

More Information

• Responsible Party: Comprehensive Research Associates
• ClinicalTrials.gov Identifier: NCT04443608
• Other Study ID Numbers: CRA-US-001
• First Posted: June 23, 2020
• Last Update Posted: May 27, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

potassium; dialysis; emergency department

Additional relevant MeSH terms:

Hyperkalemia; Water-Electrolyte Imbalance; Metabolic Diseases