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

NCT ID: NCT04443608

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-08
• Study Completion Date: 2023-06-03

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.

Conditions

Hyperkalemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Patiromer Powder for Oral Suspension [Veltassa]

Intervention Type: DRUG

Powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink

Interventions

Patiromer Powder for Oral Suspension [Veltassa]

Powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink

Intervention Type: DRUG

Placebo

Powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink

Intervention Type: DRUG

Other Intervention Names

Active drug; Inactive substance

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Comprehensive Research Associates

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stanford University School of Medicine

Stanford, California, United States

Yale University

New Haven, Connecticut, United States

Christiana Care

Newark, Delaware, United States

George Washington University

Washington D.C., District of Columbia, United States

Baystate Medical Center

Springfield, Massachusetts, United States

Wayne State University

Detroit, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Washington University of St Louis

St Louis, Missouri, United States

Mt Sinai. Icahn School of Medicine

New York, New York, United States

Maimonides Medical Center

New York, New York, United States

Stony Brook University Hospital

Stony Brook, New York, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Ohio State University. Wexner Medical Center

Columbus, Ohio, United States

JPS Health Network

Fort Worth, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

UT Memorial Hermann Hospital

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37308268 (View on PubMed)

Other Identifiers

CRA-US-001

Identifier Type: -

Identifier Source: org_study_id