Comparison of Potassium Binders in the ER

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT04585542
Phase
PHASE4
Status
Terminated

Conditions

  • Acute Hyperkalemia
  • Oral Potassium Binders

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Polyethylene Glycol 3350 — DRUG
    Nonspecific laxative comparison group.
  • Sodium Polystyrene Sulfonate Oral Suspension [SPS] — DRUG
    Potassium binder to treat hyperkalemia.
  • Patiromer — DRUG
    Potassium binder to treat hyperkalemia.
  • Sodium zirconium cyclosilicate — DRUG
    Potassium binder to treat hyperkalemia.

Study Details

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

Key Dates

Start date
Oct 20, 2020
Status verified
Apr 2026
Primary completion
Jan 31, 2025
Completion
Jan 31, 2025

Study Design

Enrollment
37 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Polyethylene glycol 3350 (MiraLax)
    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.
  • Experimental: Sodium polystyrene sulfonate (Kayexalate)
    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).
  • Experimental: Patiromer (Veltassa)
    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).
  • Experimental: Sodium zirconium cyclosilicate (Lokelma)
    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).

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, Irvine Medical CenterOrangeCalifornia92868-

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By research site
University of California, Irvine Medical Center· Orange, CA