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

August 9, 2019 updated by: Amgen

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

515

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Research Site
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Research Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Research Site
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Research Site
  • Belgium
      • Bonheiden, Belgium, 2820
        • Research Site
      • Brussel, Belgium, 1090
        • Research Site
      • Brussels, Belgium, 1200
        • Research Site
      • Liege, Belgium, 4000
        • Research Site
      • Roeselare, Belgium, 8800
        • Research Site
      • Tournai, Belgium, 7500
        • Research Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Research Site
    • British Columbia
      • New Westminister, British Columbia, Canada, V3L 0A6
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Research Site
    • Ontario
      • Toronto, Ontario, Canada, M5C 2T2
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
        • Research Site
  • Czechia
      • Novy Jicin, Czechia, 741 01
        • Research Site
      • Plzen, Czechia, 301 00
        • Research Site
      • Praha 4, Czechia, 140 21
        • Research Site
      • Usti nad Orlici, Czechia, 562 18
        • Research Site
  • France
      • Bordeaux Cedex, France, 33075
        • Research Site
      • Caen, France, 14000
        • Research Site
      • Grenoble, France, 38000
        • Research Site
      • Marseille, France, 13253
        • Research Site
      • Marseille cedex 5, France, 13385
        • Research Site
      • Perpignan Cedex, France, 66046
        • Research Site
  • Germany
      • Erfurt, Germany, 99089
        • Research Site
  • Hungary
      • Budapest, Hungary, 1076
        • Research Site
      • Budapest, Hungary, 1106
        • Research Site
      • Esztergom, Hungary, 2500
        • Research Site
      • Kecskemet, Hungary, 6000
        • Research Site
      • Miskolc, Hungary, 3526
        • Research Site
      • Zalaegerszeg, Hungary, 8900
        • Research Site
  • Israel
      • Jerusalem, Israel, 91120
        • Research Site
      • Kfar-Saba, Israel, 44281
        • Research Site
      • Tel Hashomer, Israel, 52621
        • Research Site
      • Zerifin, Israel, 70300
        • Research Site
  • Italy
      • Ancona, Italy, 60131
        • Research Site
      • Lecco, Italy, 23900
        • Research Site
      • Milano, Italy, 20142
        • Research Site
      • Quartu Sant'Elena CA, Italy, 09045
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Research Site
      • Enschede, Netherlands, 7511 JX
        • Research Site
      • Rotterdam, Netherlands, 3079 DZ
        • Research Site
      • Venlo, Netherlands, 5912 BL
        • Research Site
  • Poland
      • Gdansk, Poland, 80-952
        • Research Site
      • Golub-Dobrzyn, Poland, 87-400
        • Research Site
      • Krakow, Poland, 31-501
        • Research Site
      • Lodz, Poland, 90-153
        • Research Site
      • Rybnik, Poland, 44-200
        • Research Site
      • Warszawa, Poland, 04-749
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation, 123183
        • Research Site
      • Saint Petersburg, Russian Federation, 197110
        • Research Site
      • Yaroslavl, Russian Federation, 150062
        • Research Site
  • Spain
    • Andalucía
      • Cordoba, Andalucía, Spain, 14004
        • Research Site
      • Granada, Andalucía, Spain, 18012
        • Research Site
    • Cataluña
      • Barcelona, Cataluña, Spain, 08036
        • Research Site
      • Barcelona, Cataluña, Spain, 08035
        • Research Site
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Research Site
  • Sweden
      • Karlstad, Sweden, 651 85
        • Research Site
      • Stockholm, Sweden, 141 86
        • Research Site
      • Uppsala, Sweden, 751 85
        • Research Site
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Research Site
    • California
      • Azusa, California, United States, 91702
        • Research Site
      • Beverly Hills, California, United States, 90211
        • Research Site
      • Chula Vista, California, United States, 91910
        • Research Site
      • Fairfield, California, United States, 94534
        • Research Site
      • Glendale, California, United States, 91205
        • Research Site
      • Los Angeles, California, United States, 90022
        • Research Site
      • Northridge, California, United States, 91324
        • Research Site
      • Norwalk, California, United States, 90650
        • Research Site
      • Riverside, California, United States, 92501
        • Research Site
      • Simi Valley, California, United States, 93065
        • Research Site
    • Colorado
      • Denver, Colorado, United States, 80230
        • Research Site
    • Connecticut
      • Stamford, Connecticut, United States, 06902
        • Research Site
    • Florida
      • Lauderdale Lakes, Florida, United States, 33313
        • Research Site
      • Miami, Florida, United States, 33173
        • Research Site
      • Ocala, Florida, United States, 34471
        • Research Site
    • Georgia
      • Augusta, Georgia, United States, 30901
        • Research Site
      • Macon, Georgia, United States, 31217
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Research Site
      • Gurnee, Illinois, United States, 60031
        • Research Site
    • Indiana
      • Merrillville, Indiana, United States, 46410
        • Research Site
    • Kansas
      • Wichita, Kansas, United States, 67214-2998
        • Research Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Research Site
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Research Site
      • Fort Washington, Maryland, United States, 20744
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Research Site
    • Mississippi
      • Brookhaven, Mississippi, United States, 39601
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Research Site
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Research Site
    • New York
      • Brooklyn, New York, United States, 11212
        • Research Site
      • Fresh Meadows, New York, United States, 11365
        • Research Site
      • Great Neck, New York, United States, 11021
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Research Site
      • New Bern, North Carolina, United States, 28562
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45206
        • Research Site
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37408
        • Research Site
      • Knoxville, Tennessee, United States, 37923
        • Research Site
    • Texas
      • Arlington, Texas, United States, 76015
        • Research Site
      • Houston, Texas, United States, 77054
        • Research Site
      • Lubbock, Texas, United States, 79430
        • Research Site
    • Vermont
      • Rutland, Vermont, United States, 05701
        • Research Site
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Research Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26506-9165
        • Research Site

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
  • Subject is 18 years of age or older.
  • Subject agrees to not participate in another study of an investigational agent during the study.
  • Subject must be receiving hemodialysis 3 times weekly for at least 3 months
  • Other Inclusion Criteria may apply

Exclusion Criteria:

  • Currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(s) within 8 weeks prior to screening.
  • Other investigational procedures while participating in this study are excluded.
  • Anticipated or scheduled parathyroidectomy during the study period.
  • Subject has received a parathyroidectomy within 3 months prior to dosing.
  • Anticipated or scheduled kidney transplant during the study period.
  • Subject has known sensitivity to any of the products or components to be administered during dosing.
  • Subject has participated in a prior clinical trial of AMG 416
  • 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.
  • Subject has a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject.
  • Other Exclusion Criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
Drug: Placebo
Administered intravenously (IV) three times per week.
Experimental: Etelcalcetide
Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
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.
Other Names:
  • AMG 416

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase
Time Frame: Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).
Participants who did not have any scheduled assessments during the EAP were considered non-responders.
Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase
Time Frame: Baseline and the efficacy assessment phase (Week 20 to Week 27)
Participants who had no scheduled assessments during the EAP were considered non-responders.
Baseline and the efficacy assessment phase (Week 20 to Week 27)
Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase
Time Frame: Baseline and the Efficacy Assessment Phase (Week 20 to Week 27)
Baseline and the Efficacy Assessment Phase (Week 20 to Week 27)
Percent Change From Baseline in Predialysis Corrected Calcium During the Efficacy Assessment Phase
Time Frame: Baseline and the efficacy assessment phase (Week 20 to Week 27)
Baseline and the efficacy assessment phase (Week 20 to Week 27)
Percent Change From Baseline in Predialysis Phosphorus During the Efficacy Assessment Phase
Time Frame: Baseline and the efficacy assessment phase (Week 20 to Week 27)
Baseline and the efficacy assessment phase (Week 20 to Week 27)
Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product (cCa x P) During the Efficacy Assessment Phase
Time Frame: Baseline and the efficacy assessment phase (Week 20 to Week 27)
Baseline and the efficacy assessment phase (Week 20 to Week 27)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start (Actual)

March 12, 2013

Primary Completion (Actual)

April 14, 2014

Study Completion (Actual)

May 9, 2014

Study Registration Dates

First Submitted

February 7, 2013

First Submitted That Met QC Criteria

February 7, 2013

First Posted (Estimate)

February 11, 2013

Study Record Updates

Last Update Posted (Actual)

August 20, 2019

Last Update Submitted That Met QC Criteria

August 9, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120230
  • KAI-4169-007 (Other Identifier: KAI Pharmaceuticals, Inc (wholly owned subsidiary of Amgen Inc.))
  • 2012-002806-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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