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COMPLETEDPHASE3

Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

A Multicenter Single-arm Extension Study to Describe the Long-term Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

NCT01785875•Amgen

View on ClinicalTrials.gov

Summary

This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
•Subject must complete the treatment and follow-up period, or have been discontinued for rising intact parathyroid hormone (iPTH), from an AMG 416 phase 3 parent study prior to the start of dosing in this study: 20120229 (NCT01785849), 20120230 (NCT01788046), or 20120359 (NCT01932970).
•Subject agrees to not participate in another study of an investigational agent during the study.

Exclusion Criteria

•Currently receiving treatment in another investigational device or drug study.
•Currently receiving other investigational procedures while participating in this study.
•Subject has known sensitivity to any of the products or components to be administered during dosing.
•Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator.

Locations (208)

Research Site

Birmingham, Alabama, United States

Research Site

Pine Bluff, Arkansas, United States

Research Site

Azusa, California, United States

Research Site

Bakersfield, California, United States

Research Site

Chula Vista, California, United States

Research Site

Cudahy, California, United States

Research Site

Fairfield, California, United States

Research Site

Glendale, California, United States

Research Site

Los Angeles, California, United States

Research Site

Los Angeles, California, United States

Key Dates

Start Date

July 31, 2013

Primary Completion Date

July 1, 2015

Completion Date

July 1, 2015

Last Updated

April 10, 2019

Enrollment

891

ACTUAL participants

Conditions

Hyperparathyroidism, Secondary

Interventions

Etelcalcetide

DRUG

A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis

NCT01922843

Hyperparathyroidism, SecondaryKidney Failure, Chronic

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 10, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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