Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis

PHASE3TerminatedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

January 19, 2017

Primary Completion Date

June 11, 2025

Study Completion Date

June 11, 2025

Conditions
Secondary Hyperparathyroidism-Chronic Kidney Disease
Interventions
DRUG

Doxercalciferol (GZ427397)

"Pharmaceutical form: capsule~Route of administration: oral"

DRUG

Calcitriol

"Pharmaceutical form: capsule~Route of administration: oral"

Trial Locations (23)

10021

Mount Sinai Medical Center Site Number : 8400007, New York

11040

Cohen Children's Medical Center of NY Site Number : 8400017, New Hyde Park

15224

Children's Hospital of Pittsburgh Site Number : 8400028, Pittsburgh

23298

Virginia Commonwealth University Site Number : 8400009, Richmond

27834

East Carolina University, Brody School of Medicine Site Number : 8400025, Greenville

29605

Greenville Hospital System Site Number : 8400027, Greenville

33101

University of Miami Site Number : 8400006, Miami

33155

Nicklaus Children's Hospital Site Number : 8400008, Miami

35233

Children's Hospital Of Alabama Site Number : 8400022, Birmingham

37292

Vanderbilt University Medical Center Site Number : 8400024, Nashville

54449

Marshfield Clinic Site Number : 8400001, Marshfield

55454

University of Minnesota Site Number : 8400014, Minneapolis

60612

Rush University Medical Center Site Number : 8400020, Chicago

77030

Texas Children's Hospital Site Number : 8400013, Houston

84113

University of Utah Site Number : 8400026, Salt Lake City

90048

Cedars Sinai Medical Center Site Number : 8400033, Los Angeles

95817

UC DAVIS Medical Center Site Number : 8400005, Sacramento

06520-8017

Yale University School of Medicine Site Number : 8400029, New Haven

07601

Hackensack University Site Number : 8400010, Hackensack

07962

Goryeb Children's Hospital Site Number : 8400016, Morristown

27710-4000

Duke University Medical Center Site Number : 8400034, Durham

Unknown

Investigational Site Number : 1520003, Santiago

Investigational Site Number : 1520004, Concepción

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT02859896 - Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis | Biotech Hunter | Biotech Hunter