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.
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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
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:
- Sodium polystyrene sulfate (SPS)
- Patiromer (Veltassa)
- Sodium zirconium cyclosilicate (Lokelma)
- 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.
- Conditions
- Acute Hyperkalemia, Oral Potassium Binders
- 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 group | Role | What they receive |
|---|---|---|
| Polyethylene glycol 3350 (MiraLax) | Experimental | Participants 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) | Experimental | Participants 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) | Experimental | Participants 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) | Experimental | Participants 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.
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)
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
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
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
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.
- First posted14 Oct 2020
- Study start20 Oct 2020
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Why it stopped: Low enrollment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute HyperkalemiaStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Ling Lau, University of California, Irvine
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 30865167Betts 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 29725642Canas 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Potassium Binders in the ER
- ClinicalTrials.gov ID
- NCT04585542
- Acronym / sponsor ID
- KBindER / HS# 2020-5780
- Conditions
- Acute Hyperkalemia, Oral Potassium Binders
- Keywords
- Emergency Department
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment rate
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Posted 22 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare efficacy of 3 oral potassium binders (cation exchange resins) on lowering blood potassium, in hospital patients with acute hyperkalemia.
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:
- Sodium polystyrene sulfate (SPS)
- Patiromer (Veltassa)
- Sodium zirconium cyclosilicate (Lokelma)
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Polyethylene glycol 3350 (MiraLax) | Experimental | Drug: Polyethylene Glycol 3350Participants 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. |
| Sodium polystyrene sulfonate (Kayexalate) | Experimental | Drug: Sodium Polystyrene Sulfonate Oral Suspension [SPS]Participants 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). |
| Patiromer (Veltassa) | Experimental | Drug: PatiromerParticipants 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). |
| Sodium zirconium cyclosilicate (Lokelma) | Experimental | Drug: Sodium zirconium cyclosilicateParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Plasma potassium > 5.5 mEq/L
- Age ≥18 years
- Patient able to provide written informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyethylene Glycol 3350Also: MiraLaxNonspecific laxative comparison group. | Drug | Polyethylene glycol 3350 (MiraLax) |
| Sodium Polystyrene Sulfonate Oral Suspension [SPS]Also: KayexalatePotassium binder to treat hyperkalemia. | Drug | Sodium polystyrene sulfonate (Kayexalate) |
| PatiromerAlso: VeltassaPotassium binder to treat hyperkalemia. | Drug | Patiromer (Veltassa) |
| Sodium zirconium cyclosilicateAlso: LokelmaPotassium binder to treat hyperkalemia. | Drug | Sodium zirconium cyclosilicate (Lokelma) |
Primary outcome
Change in Blood Potassium Level at 2 Hours and 4 Hours Compared to Baseline (When Study Drug Was Administered)
Time frame: Plasma potassium level measured at 2 and 4 hours after study drug was administered
The investigators will compare the change in blood potassium after administration of the study drug, in the acute setting.
4 secondary outcomes
Length of ER or Hospital Stay
Time frame: Up to 60 days after study drug was administered
Change in Calcium and Magnesium at 4 Hours After Baseline (When Study Drug Was Administered)
Time frame: Measured at 4 hours after study drug was administered
Number of Participants Reporting GI Side Effects
Time frame: 4 hours after study drug was administered
Number of Participants Requiring Dialysis Within 8 Hours After Study Drug Was Administered
Time frame: Within 8 hours of study drug being administered
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30865167Leon SJ, Harasemiw O, Tangri N. New therapies for hyperkalemia. Curr Opin Nephrol Hypertens. 2019 May;28(3):238-244. doi: 10.1097/MNH.0000000000000500.
- Background: PubMed 29725642Betts 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.
- Derived from this study: PubMed 37016309Canas 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.
- Individual participant dataSharing planned: No. IPD will not be shared. De-identified dataset can be made available to other researchers, please contact PI Dr. Lau.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
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 3 inclusion and 9 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 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Yes. Results are posted in the registry (first posted 22 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Blood Potassium Level at 2 Hours and 4 Hours Compared to Baseline (When Study Drug Was Administered) (time frame: Plasma potassium level measured at 2 and 4 hours after study drug was administered). 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 NCT04585542, which also lists 3 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 22 Apr 2026.