A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis

Part of paid clinical trials in Los Angeles, California.

Sponsor
Amgen
Study ID
NCT03633708
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
0 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Etelcalcetide — DRUG
    Etelcalcetide has been shown to be safe and efficacious in treating adult CKD patients with SHPT by simultaneously controlling iPTH, Ca, and phosphorus and has recently been approved for use in adult patients with SHPT treated with hemodialysis in both the United States and Europe
  • Standard of Care — OTHER
    Standard of care, which can include therapy with vitamin D sterols, Ca supplementation, and/or phosphate binders

Study Details

This is a phase 3 trial of etelcalcetide in pediatric participants with secondary hyperparathyroidism (SHPT) and chronic kidney disease (CKD) on hemodialysis.

Key Dates

Start date
Apr 29, 2019
Status verified
Feb 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Etelcalcetide
    Participants are randomized in a 5:1 ratio to receive etelcalcetide in addition to standard of care versus standard of care alone.
  • Active Comparator: Standard of Care
    Participants are randomized in a 5:1 ratio to receive etelcalcetide in addition to standard of care versus standard of care alone.

Primary Outcome Measure

Percentage of Participants Achieving a ≥ 30% Reduction from Baseline in Mean iPTH During the Efficacy Assessment Period (EAP) [ Time Frame: Baseline and Weeks 20-27 ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Childrens Hospital of Los AngelesLos AngelesCalifornia90027-
Childrens Hospital ColoradoAuroraColorado80045-
Childrens Mercy HospitalKansas CityMissouri64108-
Mount Sinai Kidney Center - B1 Renal TreatmentNew YorkNew York10029-
Cincinnati Childrens Hospital Medical CenterCincinnatiOhio45229-
Cleveland Clinic FoundationClevelandOhio44195-
The Childrens Hospital at Oklahoma University Medical CenterOklahoma CityOklahoma73104-
Childrens Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Childrens Medical Center DallasDallasTexas75390-
Primary Childrens Hospital Outpatient ServicesSalt Lake CityUtah84113-

Find similar trials in Los Angeles, CA

By condition
Chronic kidney disease
By specialty
NephrologyKidney disease
By research site
Childrens Hospital of Los Angeles· Los Angeles, CAChildrens Hospital Colorado· Aurora, COChildrens Mercy Hospital· Kansas City, MOMount Sinai Kidney Center - B1 Renal Treatment· New York, NYCincinnati Childrens Hospital Medical Center· Cincinnati, OHCleveland Clinic Foundation· Cleveland, OH

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