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HyperkalemiaPhase 4PLATINUMNCT04443608

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

A Phase 4 study testing Patiromer Powder for Oral Suspension [Veltassa] in people with Hyperkalemia, run by Comprehensive Research Associates at 19 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hyperkalemia
What is being tested?
Patiromer Powder for Oral Suspension [Veltassa]
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
115 participants
Where
19 sitesUnited States
Study dates
8 Oct 2020to 3 Jun 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Hyperkalemia, defined as K+ ≥5.8 obtained via local laboratory or point-of-care testing
  • Written informed consent obtained.

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • Ohio State University. Wexner Medical Center

    Columbus, Ohio, 43210

  • Wayne State University

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • JPS Health Network

    Fort Worth, Texas, 76104

  • Baylor College of Medicine

    Houston, Texas, 77030

  • UT Memorial Hermann Hospital

    Houston, Texas, 77030

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Hennepin Healthcare Research Institute

    Minneapolis, Minnesota, 55415

  • Yale University

    New Haven, Connecticut, 06519

  • Mt Sinai. Icahn School of Medicine

    New York, New York, 10029

  • Maimonides Medical Center

    New York, New York, 11219

  • Christiana Care

    Newark, Delaware, 19718

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Washington University of St Louis

    St Louis, Missouri, 63110

  • Stanford University School of Medicine

    Stanford, California, 94305

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

  • George Washington University

    Washington D.C., District of Columbia, 20037

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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

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.

Read the 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
Being tested
Patiromer Powder for Oral Suspension [Veltassa], Placebo
Keywords
potassium, dialysis, emergency department
Medical subject headings
Hyperkalemia, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patiromer Powder for Oral Suspension [Veltassa]Drug

    Also called Active drug

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

  • PlaceboDrug

    Also called Inactive substance

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

Study groups in NCT04443608
Study groupRoleWhat they receive
VeltassaActive 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
Receives: Drug: Patiromer Powder for Oral Suspension [Veltassa]
PlaceboPlacebo 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
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The need for additional potassium-lowering medical interventions

    Net clinical benefit (mean difference in number of interventions less change in serum potassium)

    Measured: Duration of patient's emergency department visit, up to 6 hours

Secondary outcomes (5)

  1. Potassium level trends after receiving study drug

    Proportion of subjects without post-baseline potassium-related medical interventions at Hours 4, 6 and 8

    Measured: Up to 24 hours after study drug dose is given

  2. Potassium level trends after receiving study drug

    Net clinical benefit at Hour 4

    Measured: 4 hours

  3. Potassium level trends after receiving study drug

    Number of post-baseline potassium-related medical interventions up until Hours 4, 6, and 8 and ED discharge

    Measured: ED visit, up to 10 hours

  4. Potassium level trends after receiving study drug

    Proportion of subjects with sustained potassium reduction (defined as K+ ≤5.5 mEq/l and 4 hours without potassium-related medical intervention) at Hours 6 and 8

    Measured: 8 hours

  5. Potassium level trends after receiving study drug

    K+ 24 hours after ED discharge

    Measured: Up to 24 hours after study drug dose is given

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2020
  2. Study start8 Oct 2020
  3. Primary completion9 Mar 2023
  4. Study completion3 Jun 2023

Why it stopped: Recruitment window ended

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized, double-blinded, placebo-controlled parallel group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04443608
Sponsor's protocol ID
CRA-US-001
Acronym
PLATINUM
Status last verified
Apr 2023
First submitted
8 Jun 2020
Last updated
31 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rafique Z, Safdar B, Duanmu Y, Boone S, Meltzer A, Bischof JJ, Robinson D, Budden J, Budd J, Quinn CM, Milliet C, Singer AJ, Soto K, Peacock F. Patiromer utility as an adjunct treatment in patients needing urgent hyperkalaemia management (PLATINUM): a randomised controlled trial in the emergency department. BMJ Open. 2026 Feb 23;16(2):e105103. doi: 10.1136/bmjopen-2025-105103.

    PubMed 41730555

  • 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.

    PubMed 37308268

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Patiromer Powder for Oral Suspension [Veltassa] in people with Hyperkalemia, run by Comprehensive Research Associates at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Recruitment window ended). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The need for additional potassium-lowering medical interventions (time frame: Duration of patient's emergency department visit, up to 6 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04443608, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.

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