Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease 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 compared with placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) receiving hemodialysis.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

508

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

    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Research Site
      • St Leonards, New South Wales, Australia, 2065
        • Research Site
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Research Site
      • Prahan, Victoria, Australia, 3004
        • Research Site
      • Graz, Austria, 8036
        • Research Site
      • Linz, Austria, 4010
        • Research Site
      • Wien, Austria, 1090
        • Research Site
      • Aalst, Belgium, 9300
        • Research Site
      • Baudour, Belgium, 7331
        • Research Site
      • Bruxelles, Belgium, 1020
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
      • Liège, Belgium, 4000
        • Research Site
      • Quebec, Canada, G1R 2J6
        • Research Site
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • Research Site
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Research Site
      • Montreal, Quebec, Canada, H1T 2M4
        • Research Site
      • Hradec Kralove, Czechia, 500 05
        • Research Site
      • Praha 4 - Nusle, Czechia, 140 00
        • Research Site
      • Praha 6, Czechia, 169 00
        • Research Site
      • Slavkov u Brna, Czechia, 684 01
        • Research Site
      • Trinec, Czechia, 739 61
        • Research Site
      • Nantes Cedex 01, France, 44200
        • Research Site
      • Poitiers, France, 86021
        • Research Site
      • Reims Cedex, France, 51092
        • Research Site
      • Saint-Ouen, France, 93400
        • Research Site
      • Salouel Cedex 1, France, 80054
        • Research Site
      • Berlin, Germany, 12053
        • Research Site
      • Dresden, Germany, 01307
        • Research Site
      • Kiel, Germany, 24105
        • Research Site
      • Villingen-Schwenningen, Germany, 78052
        • Research Site
      • Baja, Hungary, 6500
        • Research Site
      • Budapest, Hungary, 1115
        • Research Site
      • Budapest, Hungary, 1037
        • Research Site
      • Gyor, Hungary, 9023
        • Research Site
      • Kaposvar, Hungary, 7400
        • Research Site
      • Pecs, Hungary, 7624
        • Research Site
      • Ashkelon, Israel, 78278
        • Research Site
      • Nahariya, Israel, 22100
        • Research Site
      • Tel Aviv, Israel, 64239
        • Research Site
      • Milano, Italy, 20122
        • Research Site
      • Napoli, Italy, 80131
        • Research Site
      • Pavia, Italy, 27100
        • Research Site
      • San Fermo Della Battaglia (CO), Italy, 22020
        • Research Site
      • Verona, Italy, 37126
        • Research Site
      • Bialystok, Poland, 15-540
        • Research Site
      • Warszawa, Poland, 04-141
        • Research Site
      • Warszawa, Poland, 02-097
        • Research Site
      • Warszawa, Poland, 02-006
        • Research Site
      • Wroclaw, Poland, 51-124
        • Research Site
      • Zamosc, Poland, 87-100
        • Research Site
      • Saint Petersburg, Russian Federation, 191104
        • Research Site
      • Saint Petersburg, Russian Federation, 196247
        • Research Site
      • Saint Petersburg, Russian Federation, 198510
        • Research Site
      • Saint-Petersburg, Russian Federation, 195067
        • Research Site
      • Saint-Petersburg, Russian Federation, 195257
        • Research Site
      • Madrid, Spain, 28046
        • Research Site
      • Madrid, Spain, 28041
        • Research Site
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Research Site
    • Cataluña
      • Barcelona, Cataluña, Spain, 08025
        • Research Site
      • Barcelona, Cataluña, Spain, 08003
        • Research Site
      • Cambridge, United Kingdom, CB2 2QQ
        • Research Site
      • Coventry, United Kingdom, CV2 2DX
        • Research Site
      • Glasgow, United Kingdom, G11 6NT
        • Research Site
      • London, United Kingdom, NW3 2QG
        • Research Site
      • Nottingham, United Kingdom, NG5 1PB
        • Research Site
      • Salford, United Kingdom, M6 8HD
        • Research Site
      • Sheffield, United Kingdom, S5 7AU
        • Research Site
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Research Site
    • Arkansas
      • Pine Bluff, Arkansas, United States, 71603
        • Research Site
    • California
      • Azusa, California, United States, 91702
        • Research Site
      • Covina, California, United States, 91723
        • Research Site
      • Lakewood, California, United States, 90712
        • Research Site
      • Los Angeles, California, United States, 90025
        • Research Site
      • Lynwood, California, United States, 90262
        • Research Site
      • Northridge, California, United States, 91324
        • Research Site
      • Ontario, California, United States, 91762
        • Research Site
      • Panorama City, California, United States, 91402
        • Research Site
      • Sacramento, California, United States, 95825
        • Research Site
      • Whittier, California, United States, 90603
        • Research Site
    • Florida
      • Pembroke Pines, Florida, United States, 33028
        • Research Site
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Research Site
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Research Site
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48236
        • Research Site
      • Kalamazoo, Michigan, United States, 49007
        • Research Site
      • Pontiac, Michigan, United States, 48341
        • Research Site
      • Southgate, Michigan, United States, 48195
        • Research Site
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Research Site
    • Nevada
      • Reno, Nevada, United States, 89511
        • Research Site
    • New York
      • Amherst, New York, United States, 14226
        • Research Site
      • Bronx, New York, United States, 10461
        • Research Site
      • Brooklyn, New York, United States, 11235
        • Research Site
      • Rosedale, New York, United States, 11422
        • Research Site
      • Yonkers, New York, United States, 10704
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Research Site
      • Durham, North Carolina, United States, 27704
        • Research Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19106
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19118
        • Research Site
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
        • Research Site
      • Sumter, South Carolina, United States, 29150
        • Research Site
    • Tennessee
      • Columbia, Tennessee, United States, 38401
        • Research Site
      • Nashville, Tennessee, United States, 37205
        • Research Site
    • Texas
      • Austin, Texas, United States, 78758
        • Research Site
      • Fort Worth, Texas, United States, 76105
        • Research Site
      • Fort Worth, Texas, United States, 76164
        • Research Site
      • Grand Prairie, Texas, United States, 75050
        • Research Site
      • Houston, Texas, United States, 77030
        • Research Site
      • Mansfield, Texas, United States, 76063
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
      • San Antonio, Texas, United States, 78215
        • Research Site
      • San Antonio, Texas, United States, 78205
        • Research Site
      • Tyler, Texas, United States, 75701
        • Research Site
    • Virginia
      • Fairfax, Virginia, United States, 22033
        • Research Site
      • Mechanicsville, Virginia, United States, 23116
        • Research Site
      • Norfolk, Virginia, United States, 23502
        • Research Site
    • West Virginia
      • Bluefield, West Virginia, United States, 24701
        • 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 must be receiving hemodialysis 3 times weekly for at least 3 months
  • Subject agrees to not participate in another study of an investigational agent during the study.
  • 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 (also referred to as KAI-4169).
  • Subject has received cinacalcet within the 4 weeks prior to screening labs (treatment with cinacalcet is prohibited during the study).
  • 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.
  • 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
Experimental: Etelcalcetide
Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times a week, for 26 weeks.
Administered intravenously three times per week. The starting dose was 5 mg. The dose may have been increased at 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:
  • KAI-4169
  • AMG 416
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.
Administered intravenously (IV) three times per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a > 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 Corrected Calcium Phosphorus Product 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)

Collaborators and Investigators

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

Sponsor

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

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)

May 22, 2014

Study Completion (Actual)

June 12, 2014

Study Registration Dates

First Submitted

February 5, 2013

First Submitted That Met QC Criteria

February 6, 2013

First Posted (Estimate)

February 7, 2013

Study Record Updates

Last Update Posted (Actual)

August 26, 2019

Last Update Submitted That Met QC Criteria

August 9, 2019

Last Verified

August 1, 2019

More Information

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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