RECRUITING

A Study of Etelcalcetide in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase 3 Study of Etelcalcetide in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis

Official Title

Phase 3, Randomized, Open-label, Controlled, Multiple Dose, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Etelcalcetide in Pediatric Subjects 28 Days to < 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis

Quick Facts

Study Start:2019-04-29
Study Completion:2026-01-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03633708

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Amgen Call Center
CONTACT
866-572-6436
medinfo@amgen.com

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

Childrens Hospital of Los Angeles
Los Angeles, California, 90027
United States
Childrens Hospital Colorado
Aurora, Colorado, 80045
United States
Childrens Mercy Hospital
Kansas City, Missouri, 64108
United States
Mount Sinai Kidney Center - B1 Renal Treatment
New York, New York, 10029
United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
The Childrens Hospital at Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104
United States
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Childrens Medical Center Dallas
Dallas, Texas, 75390
United States
Primary Childrens Hospital Outpatient Services
Salt Lake City, Utah, 84113
United States

Collaborators and Investigators

Sponsor: Amgen

  • MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-04-29
Study Completion Date2026-01-30

Study Record Updates

Study Start Date2019-04-29
Study Completion Date2026-01-30

Terms related to this study

Keywords Provided by Researchers

  • sHPT
  • CKD
  • pediatric
  • Secondary Hyperparathyroidism
  • Chronic Kidney disease

Additional Relevant MeSH Terms

  • Secondary Hyperparathyroidism
  • Chronic Kidney Disease