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Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide

NCT01932970 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2018-10-17

Study results available
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Summary

This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on serum corrected calcium levels when switching patients from cinacalcet to etelcalcetide (AMG 416).

Conditions

  • Hyperparathyroidism, Secondary

Interventions

DRUG

Etelcalcetide

Etelcalcetide is provided as a sterile lyophilized powder to be reconstituted with sterile water for injection.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-12
Primary Completion
2014-01-14
Completion
2017-02-14

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01932970 on ClinicalTrials.gov