Patiromer Utility as an Adjunct Treatment in Patients Needing Urgent Hyperkalemia Management

Part of paid clinical trials in Stanford, California.

Sponsor
Comprehensive Research Associates
Study ID
NCT04443608
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Patiromer Powder for Oral Suspension [Veltassa] — DRUG
    Powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink
  • Placebo — DRUG
    Powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink

Study Details

When a patient arrives to an emergency department and is found to have an elevated potassium level in the blood, there is no one standardized treatment, therefore it is not known if one treatment is superior to other. The purpose of this study is to help determine if a drug called patiromer (already approved by the FDA) can help lower potassium levels while patients are in the emergency department.

Key Dates

Start date
Oct 8, 2020
Status verified
Apr 2023
Primary completion
Mar 9, 2023
Completion
Jun 3, 2023

Study Design

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

Arms

  • Active Comparator: Veltassa
    3 packets of study drug powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink while in the emergency department
  • Placebo Comparator: Placebo
    3 packets of study drug powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink while in the emergency department

Primary Outcome Measure

The need for additional potassium-lowering medical interventions [ Time Frame: Duration of patient's emergency department visit, up to 6 hours ]

Locations (19)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicineStanfordCalifornia94305-
Yale UniversityNew HavenConnecticut06519-
Christiana CareNewarkDelaware19718-
George Washington UniversityWashington D.C.District of Columbia20037-
Baystate Medical CenterSpringfieldMassachusetts01199-
Henry Ford HospitalDetroitMichigan48202-
Wayne State UniversityDetroitMichigan48201-
Hennepin Healthcare Research InstituteMinneapolisMinnesota55415-
University of Mississippi Medical CenterJacksonMississippi39216-
Washington University of St LouisSt LouisMissouri63110-
Maimonides Medical CenterNew YorkNew York11219-
Mt Sinai. Icahn School of MedicineNew YorkNew York10029-
Stony Brook University HospitalStony BrookNew York11794-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
University of CincinnatiCincinnatiOhio45219-
Ohio State University. Wexner Medical CenterColumbusOhio43210-
JPS Health NetworkFort WorthTexas76104-
Baylor College of MedicineHoustonTexas77030-
UT Memorial Hermann HospitalHoustonTexas77030-

Find similar trials in Stanford, CA

By research site
Stanford University School of Medicine· Stanford, CAYale University· New Haven, CTChristiana Care· Newark, DEGeorge Washington University· Washington D.C., DCBaystate Medical Center· Springfield, MAHenry Ford Hospital· Detroit, MI

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