A Phase 4 interventional study of Polyethylene Glycol 3350 and Sodium Polystyrene Sulfonate Oral Suspension [SPS] in Acute Hyperkalemia and Oral Potassium Binders, sponsored by University of California, Irvine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by University of California, Irvine · Phase 4, Interventional, and Treatment
Compare efficacy of 3 oral potassium binders (cation exchange resins) on lowering blood potassium, in hospital patients with acute hyperkalemia.
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:
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.
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Exclusion Criteria:
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.
Drug: Polyethylene Glycol 3350
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).
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).
Drug: Patiromer
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).
Drug: Sodium zirconium cyclosilicate
Nonspecific laxative comparison group.
Also known as: MiraLax
Potassium binder to treat hyperkalemia.
Also known as: Kayexalate
Potassium binder to treat hyperkalemia.
Also known as: Veltassa
Potassium binder to treat hyperkalemia.
Also known as: Lokelma
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.
Time frame: Plasma potassium level measured at 2 and 4 hours after study drug was administered
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.
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)
The investigators will compare the effect of each study drug on blood calcium, phosphorus and magnesium levels, in the acute setting.
Time frame: 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).
Time frame: 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.
Time frame: Within 8 hours of study drug being administered
| Milestone | Polyethylene Glycol 3350 (MiraLax) | Sodium Polystyrene Sulfonate (Kayexalate) | Patiromer (Veltassa) | Sodium Zirconium Cyclosilicate (Lokelma) |
|---|---|---|---|---|
| Started | 8 | 9 | 10 | 10 |
| Completed | 8 | 9 | 10 | 10 |
| Not completed | 0 | 0 | 0 | 0 |
The investigators will compare the change in blood potassium after administration of the study drug, in the acute setting.
| mEq/L | Polyethylene Glycol 3350 (MiraLax) | Sodium Polystyrene Sulfonate (Kayexalate) | Patiromer (Veltassa) | Sodium Zirconium Cyclosilicate (Lokelma) |
|---|---|---|---|---|
| 2 hours | -0.40 ± 0.49 | -0.20 ± 0.42 | -0.65 ± 0.89 | -0.69 ± 0.40 |
| 4 hours | -0.25 ± 0.49 | -0.64 ± 0.66 | -0.60 ± 0.72 | -0.58 ± 0.66 |
The investigators will compare length of ER or hospital stay associated with each study drug, obtained from medical chart review.
| days | Polyethylene Glycol 3350 (MiraLax) | Sodium Polystyrene Sulfonate (Kayexalate) | Patiromer (Veltassa) | Sodium Zirconium Cyclosilicate (Lokelma) |
|---|---|---|---|---|
| Length of ER or Hospital Stay | 14 (4.25 to 19.75) | 4 (2 to 12.75) | 7 (4 to 21.5) | 8 (3 to 37) |
The investigators will compare the effect of each study drug on blood calcium, phosphorus and magnesium levels, in the acute setting.
| mg/dL | Polyethylene Glycol 3350 (MiraLax) | Sodium Polystyrene Sulfonate (Kayexalate) | Patiromer (Veltassa) | Sodium Zirconium Cyclosilicate (Lokelma) |
|---|---|---|---|---|
| Change in calcium at 4 hours | 0.15 ± 0.23 | -0.16 ± 0.45 | 0.36 ± 0.42 | -0.07 ± 0.45 |
| Change in magnesium at 4 hours | -0.03 ± 0.23 | 0.17 ± 0.41 | 0.15 ± 0.14 | -0.08 ± 0.23 |
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).
| Participants | Polyethylene Glycol 3350 (MiraLax) | Sodium Polystyrene Sulfonate (Kayexalate) | Patiromer (Veltassa) | Sodium Zirconium Cyclosilicate (Lokelma) |
|---|---|---|---|---|
| Number of Participants Reporting GI Side Effects | 2 | 3 | 2 | 1 |
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.
| Participants | Polyethylene Glycol 3350 (MiraLax) | Sodium Polystyrene Sulfonate (Kayexalate) | Patiromer (Veltassa) | Sodium Zirconium Cyclosilicate (Lokelma) |
|---|---|---|---|---|
| Number of Participants Requiring Dialysis Within 8 Hours After Study Drug Was Administered | 0 | 1 | 0 | 0 |
Collected over 4 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Polyethylene Glycol 3350 (MiraLax) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Sodium Polystyrene Sulfonate (Kayexalate) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Patiromer (Veltassa) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Sodium Zirconium Cyclosilicate (Lokelma) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Continuous(Years) | Polyethylene Glycol 3350 (MiraLax) | Sodium Polystyrene Sulfonate (Kayexalate) | Patiromer (Veltassa) | Sodium Zirconium Cyclosilicate (Lokelma) | Total |
|---|---|---|---|---|---|
| Mean | 62 ± 12 | 66 ± 19 | 56 ± 21 | 62 ± 15 | 61 ± 17 |
| Sex: Female, Male(Participants) | Polyethylene Glycol 3350 (MiraLax) | Sodium Polystyrene Sulfonate (Kayexalate) | Patiromer (Veltassa) | Sodium Zirconium Cyclosilicate (Lokelma) | Total |
|---|---|---|---|---|---|
| Female | 2 | 3 | 4 | 5 | 14 |
| Male | 6 | 6 | 6 | 5 | 23 |
| Race (NIH/OMB)(Participants) | Polyethylene Glycol 3350 (MiraLax) | Sodium Polystyrene Sulfonate (Kayexalate) | Patiromer (Veltassa) | Sodium Zirconium Cyclosilicate (Lokelma) | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 1 | 1 | 0 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 |
| White | 6 | 8 | 9 | 10 | 33 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 | 0 | 2 |
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Plan to share: 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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