Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Vifor Pharma, Inc.
Study ID
NCT05766839
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
0 Years - 11 Years
Healthy Volunteers
Not accepted

Interventions

  • Patiromer — DRUG
    Patiromer will be given once daily; In Cohort 3, depending on the dose and the study participant's age, the total daily dose might be split

Study Details

A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia.

Key Dates

Start date
Apr 6, 2025
Status verified
May 2026
Primary completion
Dec 1, 2029
Completion
Dec 1, 2030

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patiromer
    4-week pharmacodynamic /dose-ranging period Cohort 1: 6 to less than(\<)12 years of age Cohort 2: 2 to \<6 years of age Cohort 3: 0 to \<2 years of age; In Cohort 3, a minimum of 3 study participants will be assessed in the subgroup of 0 to \<6 months and another 3 study participants in the subgroup 6 to \<24 months of age.

Primary Outcome Measure

Change in potassium levels (mmol/L) [ Time Frame: From baseline to Day 28 ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045-
UF Health Pediatric Multispecialty Center SiteJacksonvilleFlorida32207-
Miller School of Medicine, University of MiamiMiamiFlorida33124-
Arnold Palmer Hospital for ChildrenOrlandoFlorida32806-
Augusta University - Children's Hospital of GeorgiaAugustaGeorgia30912-
University of Illinois College of MedicinePeoriaIllinois61605-
Boston Children's HospitalBostonMassachusetts02115-
Children's Mercy Hospitals and ClinicsKansas CityMissouri64108-
Duke University HospitalDurhamNorth Carolina27710-
Duke University Hospital & Medical CenterDurhamNorth Carolina27710-
The Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Vanderbilt Children's Hospital NeurologyNashvilleTennessee37232-
Texas Tech University Health Sciences Center AmarilloAmarilloTexas79106-

Find similar trials in Aurora, CO

By research site
Children's Hospital Colorado· Aurora, COUF Health Pediatric Multispecialty Center Site· Jacksonville, FLMiller School of Medicine, University of Miami· Miami, FLArnold Palmer Hospital for Children· Orlando, FLAugusta University - Children's Hospital of Georgia· Augusta, GAUniversity of Illinois College of Medicine· Peoria, IL

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