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

September 20, 2018 updated by: Amgen

A Multicenter, Multiple-dose, Single-arm Study to Switch Hemodialysis Subjects With Secondary Hyperparathyroidism From Oral Cinacalcet HCl to Intravenous AMG 416

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

158

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

  • United States
    • California
      • Alhambra, California, United States, 91801
        • Research Site
      • Azusa, California, United States, 91702
        • Research Site
      • Bakersfield, California, United States, 93308
        • Research Site
      • Chula Vista, California, United States, 91910
        • Research Site
      • La Mesa, California, United States, 91942
        • Research Site
      • Los Angeles, California, United States, 90022
        • Research Site
      • Lynwood, California, United States, 90262
        • Research Site
      • Riverside, California, United States, 92505
        • Research Site
      • Whittier, California, United States, 90603
        • Research Site
    • Colorado
      • Arvada, Colorado, United States, 80002
        • Research Site
    • Connecticut
      • North Haven, Connecticut, United States, 06473
        • Research Site
    • Florida
      • Coral Springs, Florida, United States, 33071
        • Research Site
      • Hollywood, Florida, United States, 33021
        • Research Site
      • Miami, Florida, United States, 33150
        • Research Site
      • Pembroke Pines, Florida, United States, 33028
        • Research Site
      • Pinecrest, Florida, United States, 33156
        • Research Site
      • Tampa, Florida, United States, 33614
        • Research Site
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Research Site
    • Illinois
      • Evergreen Park, Illinois, United States, 60805
        • Research Site
    • Indiana
      • Michigan City, Indiana, United States, 46360
        • Research Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Research Site
      • Lafayette, Louisiana, United States, 70506
        • Research Site
    • Mississippi
      • Columbus, Mississippi, United States, 39705
        • Research Site
      • Gulfport, Mississippi, United States, 39501
        • Research Site
    • Missouri
      • Farmington, Missouri, United States, 63640
        • Research Site
      • Kansas City, Missouri, United States, 64111
        • Research Site
      • Saint Louis, Missouri, United States, 63136
        • Research Site
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Research Site
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Research Site
    • New York
      • College Point, New York, United States, 11356
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19106
        • Research Site
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
        • Research Site
    • Texas
      • Arlington, Texas, United States, 76015
        • Research Site
      • Greenville, Texas, United States, 75402
        • Research Site
      • Houston, Texas, United States, 77004
        • Research Site
      • McAllen, Texas, United States, 78503
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
    • Virginia
      • Fairfax, Virginia, United States, 22033
        • Research Site
      • Hampton, Virginia, United States, 23666
        • 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 is 18 years of age or older at the time of informed consent.
  • Subject must be receiving maintenance hemodialysis 3 times weekly for at least 8 weeks.
  • Subject must have SHPT as defined by having a mean of 3 consecutive central laboratory screening predialysis serum parathyroid hormone (PTH) values ≥ 200 pg/mL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet.
  • Subject must have a mean of 3 consecutive central laboratory screening predialysis serum corrected calcium (cCa) values ≥ 7.5 mg/dL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet.
  • Subject must be on a stable dose of cinacalcet before screening (defined as no dose change within the 4 weeks prior to screening).
  • Other Inclusion Criteria may apply.

Exclusion Criteria

  • Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s).
  • Subject has received AMG 416 in a prior clinical trial of AMG 416 (also known as KAI-4169).
  • Subject has known sensitivity to any of the products or components of AMG 416 to be administered during dosing.
  • Subject is unwilling to use effective contraception during the study, and for women, up to a period of up to 3 months after the last dose of AMG 416.
  • Subject is pregnant or nursing.
  • Anticipated or scheduled parathyroidectomy during the study period.
  • Subject has received a parathyroidectomy within 6 months prior to dosing.
  • 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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Etelcalcetide
Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
Drug: Etelcalcetide
Etelcalcetide is provided as a sterile lyophilized powder to be reconstituted with sterile water for injection.
Other Names:
  • AMG 416
  • Parsabiv™
  • KAI 4169

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL During the 4-week Treatment Period
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent Change From Baseline in Parathyroid Hormone During the Treatment Period
Time Frame: Baseline and weeks 2, 3 and 4
Baseline and weeks 2, 3 and 4
Percentage of Participants With Serum Corrected Calcium < 8.3 mg/dL During the 4-week Treatment Period
Time Frame: 4 weeks
4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events
Time Frame: From the first dose of study drug up to 30 days after the last dose; 8 weeks
From the first dose of study drug up to 30 days after the last dose; 8 weeks
Percentage of Participants With Symptomatic Hypocalcemia During the 4-week Treatment Period
Time Frame: From the first dose of study drug up to 30 days after the last dose; 8 weeks
Hpocalcemia was used for events of decreased calcium accompanied by clinical signs and symptoms of hypocalcemia.
From the first dose of study drug up to 30 days after the last dose; 8 weeks

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.

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)

August 12, 2013

Primary Completion (Actual)

January 14, 2014

Study Completion (Actual)

February 14, 2017

Study Registration Dates

First Submitted

August 28, 2013

First Submitted That Met QC Criteria

August 28, 2013

First Posted (Estimate)

August 30, 2013

Study Record Updates

Last Update Posted (Actual)

October 17, 2018

Last Update Submitted That Met QC Criteria

September 20, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120359
  • KAI-4169 (Other Identifier: KAI Pharmaceuticals (wholly owned subsidiary of Amgen Inc.))
  • 2013-000964-28 (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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