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

  • STATUS
    Recruiting
  • days left to enroll
    48
  • participants needed
    300
  • sponsor
    Comprehensive Research Associates
Updated on 6 June 2022

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.

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.

Details
Condition Hyperkalemia
Treatment Placebo, Patiromer Powder for Oral Suspension [Veltassa]
Clinical Study IdentifierNCT04443608
SponsorComprehensive Research Associates
Last Modified on6 June 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note