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Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis

NCT02102204 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 902

Last updated 2017-11-17

Study results available
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Summary

This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on hemodialysis.

Conditions

  • Hyperparathyroidism, Secondary

Interventions

DRUG

Etelcalcetide

Etelcalcetide was supplied as a sterile, preservative-free, ready-to-administer aqueous solution.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-03-25
Primary Completion
2016-11-04
Completion
2017-06-26

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • New Zealand
  • Poland
  • Portugal
  • Russia
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)

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 NCT02102204 on ClinicalTrials.gov