Comparison of Potassium Binders in the ER

NCT04585542 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: HS# 2020-5780
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Hyperkalemia; Oral Potassium Binders

Keywords

Emergency Department

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

• Length of ER or Hospital Stay

  Up to 60 days after study drug was administered

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

  Measured at 4 hours after study drug was administered

• Number of Participants Reporting GI Side Effects

  4 hours after study drug was administered

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

  Within 8 hours of study drug being administered

Study Arms (4)

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.

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).

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).

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).

Drug: Sodium zirconium cyclosilicate

Interventions

Polyethylene Glycol 3350 DRUG

Nonspecific laxative comparison group.

Also known as: MiraLax

Polyethylene glycol 3350 (MiraLax)

Sodium Polystyrene Sulfonate Oral Suspension [SPS] DRUG

Potassium binder to treat hyperkalemia.

Also known as: Kayexalate

Sodium polystyrene sulfonate (Kayexalate)

Patiromer DRUG

Potassium binder to treat hyperkalemia.

Also known as: Veltassa

Patiromer (Veltassa)

Sodium zirconium cyclosilicate DRUG

Potassium binder to treat hyperkalemia.

Also known as: Lokelma

Sodium zirconium cyclosilicate (Lokelma)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Related Publications (3)

• 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.

  PMID: 30865167 BACKGROUND

• 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.

  PMID: 29725642 BACKGROUND

• 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.

  PMID: 37016309 DERIVED

MeSH Terms

Conditions

Emergencies

Interventions

polyethylene glycol 3350; polystyrene sulfonic acid; patiromer; sodium zirconium cyclosilicate

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Wei Ling Lau, MD
• Organization: University of California Irvine

wllau@uci.edu

714-456-5142

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants and ER physicians are blinded to study drug allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Nephrology, Dpt of Medicine

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 14, 2020
• Study Start: October 20, 2020
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: April 22, 2026
• Results First Posted: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)