AzTrials
AzTrials

Acute HyperkalemiaPhase 4KBindERNCT04585542

Comparison of Potassium Binders in the ER

A Phase 4 study testing Polyethylene Glycol 3350, Sodium Polystyrene Sulfonate Oral Suspension [SPS] and Patiromer in people with Acute Hyperkalemia and Oral Potassium Binders, run by University of California, Irvine at 1 site in United States.

Terminated

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

Official record

Search all trials

Trial summary

Compare efficacy of 3 oral potassium binders (cation exchange resins) on lowering blood potassium, in hospital patients with acute hyperkalemia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Hyperkalemia, Oral Potassium Binders
What is being tested?
Polyethylene Glycol 3350, Sodium Polystyrene Sulfonate Oral Suspension [SPS] and Patiromer
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteUnited States
Study dates
20 Oct 2020to 31 Jan 2025
Phase
Phase 4

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

  • Plasma potassium > 5.5 mEq/L
  • Age ≥18 years
  • Patient able to provide written informed consent

Who cannot join

  • Recent bowel surgery
  • Ileus or bowel obstruction
  • Pseudohyperkalemia signs and symptoms, such as excessive fist clenching, hemolyzed blood specimen, severe leukocytosis or thrombocytosis
  • Pregnancy
  • Active psychiatric disorder
  • Diabetic ketoacidosis or hyperkalemia caused by any condition for which a therapy directed against the underlying cause of hyperkalemia would be a better treatment option
Show all 9Show fewer
  • Dialysis session expected within 4 hours after randomization
  • History of hypersensitivity to sodium polystyrene sulfonate resin or patiromer
  • Concurrent use of sorbitol (due to increased risk of intestinal necrosis when used with sodium polystyrene sulfonate)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California, Irvine Medical Center

    Orange, California, 92868

Other trials in United States

About this study

Compare efficacy of 3 oral potassium binders (cation exchange resins) on lowering blood potassium, in hospital patients with acute hyperkalemia.

Read the detailed description

Adult patients presenting to the Emergency Room or currently hospitalized at UC Irvine (not in ICU level of care) with plasma potassium >5.5 mEq/L (who meet inclusion/exclusion criteria and provide written informed consent) will be randomized to a one-time dose of one of the following oral medications:

  1. Sodium polystyrene sulfate (SPS)
  2. Patiromer (Veltassa)
  3. Sodium zirconium cyclosilicate (Lokelma)
  4. Nonspecific laxative: polyethylene glycol 3350 (MiraLax)

Participants will receive standard-of-care hyperkalemia therapy as well.

Blood potassium will be checked at 2 and 4 hours after dose of study drug. Participants will complete a symptom and palatability questionnaire at 4 hours.

The purpose of this research study is to determine the effects of various potassium binders (SPS, patiromer, zirconium) vs a non-specific laxative (MiraLax) in hospital patients found to have elevated blood potassium > 5.5 mEq/L. Hyperkalemia is a fairly common electrolyte disorder with varying levels of severity. Moderate hyperkalemia is in the range 5.5-5.9 mEq/L while severe hyperkalemia is ≥6.0 mEq/L or if patient is symptomatic: muscle weakness/paralysis or with EKG changes (e.g., peaked T waves, widening QRS, arrhythmias including ventricular fibrillation or asystole). Hyperkalemia is most commonly associated with kidney insufficiency, metabolic acidosis, and the use of medications such as renin-angiotensin-aldosterone system inhibitors.

In an emergency, the main goal is to reverse adverse cardiac effects and shift potassium into cells using interventions such as insulin/glucose and albuterol. However, these are only temporary measures. To remove potassium from the body, agents or interventions that may be used include cation exchange resins (potassium binders), loop diuretics, or dialysis. For over 50 years the only available oral cation exchange resin has been sodium polystyrene sulfonate. In recent years, two new agents (patiromer and zirconium) have been approved by the FDA for chronic management of hyperkalemia.

The cation exchange resins have not been studied head-to-head for acute hyperkalemia. This is a critical knowledge gap since acute hyperkalemia poses a significant burden on the healthcare system. In claims data analysis of 80,000 patients, half with hyperkalemia and half without, the patients with hyperkalemia had 4 times higher rate of inpatient admissions, 7 times longer average length of stay, and 30-day hospital readmission rate 14.21% vs 9.86% in the non-hyperkalemia cohort. The findings from our study will help inform decision-making guidelines for the treatment of acute hyperkalemia.

Being tested
Polyethylene Glycol 3350, Sodium Polystyrene Sulfonate Oral Suspension [SPS], Patiromer, Sodium zirconium cyclosilicate
Keywords
Emergency Department
Medical subject headings
Emergencies

What participants receive

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

  • Polyethylene Glycol 3350Drug

    Also called MiraLax

    Nonspecific laxative comparison group.

  • Sodium Polystyrene Sulfonate Oral Suspension [SPS]Drug

    Also called Kayexalate

    Potassium binder to treat hyperkalemia.

  • PatiromerDrug

    Also called Veltassa

    Potassium binder to treat hyperkalemia.

  • Sodium zirconium cyclosilicateDrug

    Also called Lokelma

    Potassium binder to treat hyperkalemia.

Study groups in NCT04585542
Study groupRoleWhat they receive
Polyethylene glycol 3350 (MiraLax)ExperimentalParticipants will be randomized to one of four study arms. They will receive one dose of the study drug. One study arm is the nonspecific laxative MiraLax (one dose of 17g). Since constipation can contribute to hyperkalemia, this arm will study the effect of treating constipation instead of direct cation exchange for potassium in the gut.
Receives: Drug: Polyethylene Glycol 3350
Sodium polystyrene sulfonate (Kayexalate)ExperimentalParticipants will be randomized to one of four study arms. They will receive one dose of the study drug. The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
Receives: Drug: Sodium Polystyrene Sulfonate Oral Suspension [SPS]
Patiromer (Veltassa)ExperimentalParticipants will be randomized to one of four study arms. They will receive one dose of the study drug. The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
Receives: Drug: Patiromer
Sodium zirconium cyclosilicate (Lokelma)ExperimentalParticipants will be randomized to one of four study arms. They will receive one dose of the study drug. The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
Receives: Drug: Sodium zirconium cyclosilicate

What is being measured

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

  1. Change in Blood Potassium Level at 2 Hours and 4 Hours Compared to Baseline (When Study Drug Was Administered)

    The investigators will compare the change in blood potassium after administration of the study drug, in the acute setting.

    Measured: Plasma potassium level measured at 2 and 4 hours after study drug was administered

Secondary outcomes (4)
  1. Length of ER or Hospital Stay

    The investigators will compare length of ER or hospital stay associated with each study drug, obtained from medical chart review.

    Measured: Up to 60 days after study drug was administered

  2. Change in Calcium and Magnesium at 4 Hours After Baseline (When Study Drug Was Administered)

    The investigators will compare the effect of each study drug on blood calcium, phosphorus and magnesium levels, in the acute setting.

    Measured: Measured at 4 hours after study drug was administered

  3. Number of Participants Reporting GI Side Effects

    Participants completed a 1-page brief survey assessing for potential GI side effects with the study drug including bloating, nausea and diarrhea (answers are yes/no).

    Measured: 4 hours after study drug was administered

  4. Number of Participants Requiring Dialysis Within 8 Hours After Study Drug Was Administered

    The investigators will assess whether dialysis was needed to manage hyperkalemia, within 8 hours of the study drug being given. This will be assessed from medical chart review.

    Measured: Within 8 hours of study drug being administered

Timeline

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

  1. First posted14 Oct 2020
  2. Study start20 Oct 2020
  3. Primary completion31 Jan 2025
  4. Study completion31 Jan 2025

Why it stopped: Low enrollment rate

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
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04585542
Sponsor's protocol ID
HS# 2020-5780
Acronym
KBindER
Status last verified
Apr 2026
First submitted
30 Sep 2020
Last updated
22 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared. De-identified dataset can be made available to other researchers, please contact PI Dr. Lau.

Publications

  • Leon SJ, Harasemiw O, Tangri N. New therapies for hyperkalemia. Curr Opin Nephrol Hypertens. 2019 May;28(3):238-244. doi: 10.1097/MNH.0000000000000500.

    PubMed 30865167
  • Betts KA, Woolley JM, Mu F, Xiang C, Tang W, Wu EQ. The Cost of Hyperkalemia in the United States. Kidney Int Rep. 2017 Nov 14;3(2):385-393. doi: 10.1016/j.ekir.2017.11.003. eCollection 2018 Mar.

    PubMed 29725642
  • Canas AE, Troutt HR, Jiang L, Tonthat S, Darwish O, Ferrey A, Lotfipour S, Kalantar-Zadeh K, Hanna R, Lau WL. A randomized study to compare oral potassium binders in the treatment of acute hyperkalemia. BMC Nephrol. 2023 Apr 5;24(1):89. doi: 10.1186/s12882-023-03145-x.

    PubMed 37016309

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in