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Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

NCT01788046 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 515

Last updated 2019-08-20

Study results available
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Summary

This study is designed to assess the efficacy and safety of etelcalcetide (AMG 416) compared with placebo in the treatment of SHPT in CKD patients receiving hemodialysis.

Conditions

  • Hyperparathyroidism, Secondary

Interventions

DRUG

Etelcalcetide

Administered intravenously three times per week. The starting dose was 5 mg. The dose may have been increased at weeks 5, 9, 13, and 17 (4-week intervals) by 2.5 mg or 5 mg on the basis of the predialysis parathyroid hormone and corrected calcium concentrations obtained in the prior week. The minimum dose was 2.5 mg and the maximum dose was 15 mg.

DRUG

Placebo

Administered intravenously (IV) three times per week.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-03-12
Primary Completion
2014-04-14
Completion
2014-05-09

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Russia
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
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 NCT01788046 on ClinicalTrials.gov