Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

April 1, 2019 updated by: Amgen

A Multicenter Single-arm Extension Study to Describe the Long-term 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 describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

891

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
      • 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
      • Parkville, Victoria, Australia, 3050
        • 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
      • Bonheiden, Belgium, 2820
        • Research Site
      • Brussel, Belgium, 1090
        • Research Site
      • Brussels, Belgium, 1200
        • Research Site
      • Bruxelles, Belgium, 1020
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
      • Liege, Belgium, 4000
        • Research Site
      • Liège, Belgium, 4000
        • Research Site
      • Roeselare, Belgium, 8800
        • Research Site
      • Tournai, Belgium, 7500
        • Research Site
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Research Site
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • Research Site
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Research Site
      • Montreal, Quebec, Canada, H4J 1C5
        • Research Site
      • Montreal, Quebec, Canada, H1T 2M4
        • Research Site
      • Hradec Kralove, Czechia, 500 05
        • Research Site
      • Novy Jicin, Czechia, 741 01
        • Research Site
      • Plzen, Czechia, 301 00
        • Research Site
      • Praha 4, Czechia, 140 21
        • 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
      • Usti nad Orlici, Czechia, 562 18
        • Research Site
      • Bordeaux Cedex, France, 33076
        • Research Site
      • Caen, France, 14000
        • Research Site
      • La Tronche cedex, France, 38701
        • Research Site
      • Marseille, France, 13253
        • Research Site
      • Marseille cedex 5, France, 13385
        • Research Site
      • Poitiers, France, 86021
        • Research Site
      • Reims Cedex, France, 51092
        • Research Site
      • Saint-Ouen, France, 93400
        • Research Site
      • Berlin, Germany, 12053
        • Research Site
      • Dresden, Germany, 01307
        • Research Site
      • Erfurt, Germany, 99089
        • Research Site
      • Villingen-Schwenningen, Germany, 78052
        • Research Site
      • Baja, Hungary, 6500
        • Research Site
      • Budapest, Hungary, 1076
        • Research Site
      • Budapest, Hungary, 1106
        • Research Site
      • Budapest, Hungary, 1037
        • Research Site
      • Esztergom, Hungary, 2500
        • Research Site
      • Gyor, Hungary, 9023
        • Research Site
      • Kaposvar, Hungary, 7400
        • Research Site
      • Kecskemet, Hungary, 6000
        • Research Site
      • Miskolc, Hungary, 3526
        • Research Site
      • Pecs, Hungary, 7624
        • Research Site
      • Zalaegerszeg, Hungary, 8900
        • Research Site
      • Ashkelon, Israel, 78278
        • Research Site
      • Jerusalem, Israel, 91120
        • Research Site
      • Kfar-Saba, Israel, 44281
        • Research Site
      • Nahariya, Israel, 22100
        • Research Site
      • Tel Aviv, Israel, 64239
        • Research Site
      • Tel Hashomer, Israel, 52621
        • Research Site
      • Zerifin, Israel, 70300
        • Research Site
      • Ancona, Italy, 60131
        • Research Site
      • Lecco, Italy, 23900
        • Research Site
      • Milano, Italy, 20122
        • Research Site
      • Milano, Italy, 20142
        • Research Site
      • Pavia, Italy, 27100
        • Research Site
      • Verona, Italy, 37126
        • Research Site
      • Amsterdam, Netherlands, 1081 HV
        • Research Site
      • Enschede, Netherlands, 7511 JX
        • Research Site
      • Rotterdam, Netherlands, 3079 DZ
        • Research Site
      • Venlo, Netherlands, 5912 BL
        • Research Site
      • Bialystok, Poland, 15-540
        • Research Site
      • 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, 02-097
        • Research Site
      • Warszawa, Poland, 04-749
        • Research Site
      • Warszawa, Poland, 02-006
        • Research Site
      • Zamosc, Poland, 87-100
        • Research Site
      • Moscow, Russian Federation, 123183
        • Research Site
      • Saint Petersburg, Russian Federation, 191104
        • Research Site
      • Saint Petersburg, Russian Federation, 196247
        • Research Site
      • Saint Petersburg, Russian Federation, 197110
        • Research Site
      • Saint Petersburg, Russian Federation, 198510
        • Research Site
      • Saint-Petersburg, Russian Federation, 195067
        • Research Site
      • Saint-Petersburg, Russian Federation, 195257
        • Research Site
      • Yaroslavl, Russian Federation, 150062
        • Research Site
      • Madrid, Spain, 28041
        • Research Site
    • Andalucía
      • Cordoba, Andalucía, Spain, 14004
        • Research Site
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Research Site
    • Cataluña
      • Barcelona, Cataluña, Spain, 08025
        • Research Site
      • Barcelona, Cataluña, Spain, 08036
        • Research Site
      • Barcelona, Cataluña, Spain, 08003
        • Research Site
      • Barcelona, Cataluña, Spain, 08035
        • Research Site
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Research Site
      • Karlstad, Sweden, 651 85
        • Research Site
      • Stockholm, Sweden, 141 86
        • Research Site
      • Uppsala, Sweden, 751 85
        • Research Site
      • Cambridge, United Kingdom, CB2 2QQ
        • Research Site
      • Coventry, United Kingdom, CV2 2DX
        • Research Site
      • London, United Kingdom, NW3 2QG
        • Research Site
      • Nottingham, United Kingdom, NG5 1PB
        • 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
      • Bakersfield, California, United States, 93308
        • Research Site
      • Chula Vista, California, United States, 91910
        • Research Site
      • Cudahy, California, United States, 90201
        • Research Site
      • Fairfield, California, United States, 94534
        • Research Site
      • Glendale, California, United States, 91205
        • Research Site
      • Los Angeles, California, United States, 90025
        • Research Site
      • Los Angeles, California, United States, 90022
        • Research Site
      • Los Angeles, California, United States, 90048
        • Research Site
      • Lynwood, California, United States, 90262
        • Research Site
      • Northridge, California, United States, 91324
        • Research Site
      • Norwalk, California, United States, 90650
        • Research Site
      • Ontario, California, United States, 91762
        • Research Site
      • Riverside, California, United States, 92501
        • Research Site
      • San Gabriel, California, United States, 91776
        • Research Site
      • Simi Valley, California, United States, 93065
        • Research Site
      • Whittier, California, United States, 90603
        • Research Site
    • Colorado
      • Arvada, Colorado, United States, 80002
        • Research Site
      • Denver, Colorado, United States, 80230
        • Research Site
    • Connecticut
      • Stamford, Connecticut, United States, 06902
        • Research Site
    • Florida
      • Coral Springs, Florida, United States, 33071
        • Research Site
      • Lauderdale Lakes, Florida, United States, 33313
        • Research Site
      • Miami, Florida, United States, 33173
        • Research Site
      • Miami, Florida, United States, 33150
        • Research Site
      • Ocala, Florida, United States, 34471
        • Research Site
      • Pembroke Pines, Florida, United States, 33025
        • Research Site
      • Pinecrest, Florida, United States, 33156
        • Research Site
      • Tampa, Florida, United States, 33614
        • Research Site
    • Georgia
      • Augusta, Georgia, United States, 30901
        • Research Site
      • Macon, Georgia, United States, 31217
        • Research Site
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Research Site
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Research Site
      • Gurnee, Illinois, United States, 60031
        • Research Site
    • Indiana
      • Merrillville, Indiana, United States, 46410
        • Research Site
      • Michigan City, Indiana, United States, 46360
        • Research Site
    • Kansas
      • Wichita, Kansas, United States, 67214-2998
        • Research Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Research Site
      • Lafayette, Louisiana, United States, 70503
        • Research Site
      • Shreveport, Louisiana, United States, 71101
        • Research Site
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Research Site
      • Detroit, Michigan, United States, 48236
        • Research Site
      • Kalamazoo, Michigan, United States, 49007
        • Research Site
      • Pontiac, Michigan, United States, 48341
        • Research Site
    • Mississippi
      • Brookhaven, Mississippi, United States, 39601
        • Research Site
      • Columbus, Mississippi, United States, 39705
        • Research Site
      • Gulfport, Mississippi, United States, 39501
        • Research Site
      • Tupelo, Mississippi, United States, 38801
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Research Site
      • Saint Louis, Missouri, United States, 63136
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Research Site
      • Reno, Nevada, United States, 89511
        • Research Site
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Research Site
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Research Site
    • New York
      • Bronx, New York, United States, 10461
        • Research Site
      • Brooklyn, New York, United States, 11235
        • Research Site
      • Brooklyn, New York, United States, 11212
        • Research Site
      • Great Neck, New York, United States, 11021
        • Research Site
      • Orchard Park, New York, United States, 14127
        • Research Site
      • Ridgewood, New York, United States, 11385
        • Research Site
      • Rosedale, New York, United States, 11422
        • Research Site
      • Yonkers, New York, United States, 10704
        • Research Site
    • North Carolina
      • Carrboro, North Carolina, United States, 27510
        • Research Site
      • Charlotte, North Carolina, United States, 28207
        • Research Site
      • Durham, North Carolina, United States, 27704
        • Research Site
      • New Bern, North Carolina, United States, 28562
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45206
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Research Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19106
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19118
        • Research Site
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Research Site
      • Orangeburg, South Carolina, United States, 29118
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37408
        • Research Site
      • Columbia, Tennessee, United States, 38401
        • Research Site
      • Knoxville, Tennessee, United States, 37923
        • Research Site
      • Nashville, Tennessee, United States, 37205
        • Research Site
    • Texas
      • Arlington, Texas, United States, 76015
        • Research Site
      • Austin, Texas, United States, 78758
        • Research Site
      • Edinburg, Texas, United States, 78539
        • Research Site
      • Fort Worth, Texas, United States, 76104
        • 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, 77004
        • Research Site
      • Houston, Texas, United States, 77054
        • Research Site
      • Lubbock, Texas, United States, 79430
        • 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
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Research Site
      • Alexandria, Virginia, United States, 22306
        • Research Site
      • Fairfax, Virginia, United States, 22033
        • Research Site
      • Hampton, Virginia, United States, 23666
        • 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 must complete the treatment and follow-up period, or have been discontinued for rising intact parathyroid hormone (iPTH), from an AMG 416 phase 3 parent study prior to the start of dosing in this study: 20120229 (NCT01785849), 20120230 (NCT01788046), or 20120359 (NCT01932970).
  • 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.
  • Currently receiving other investigational procedures while participating in this study.
  • Subject has known sensitivity to any of the products or components to be administered during dosing.
  • 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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Etelcalcetide
Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Administered by bolus injection into the venous line of the dialysis circuit at the end of hemodialysis treatment, and prior to or during rinse-back with each hemodialysis session (ie, 3 times per week).
Other Names:
  • AMG 416

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs)
Time Frame: From first dose until 30 days after last dose; the treatment period was 52 weeks.
Treatment-related adverse events are those the investigator indicated as having a reasonable possibility of having been caused by etelcalcetide. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event.
From first dose until 30 days after last dose; the treatment period was 52 weeks.
Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4
Time Frame: 52 weeks
Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 0 represents values in the normal range and grade 4 represents values with life-threatening consequences and urgent intervention indicated.
52 weeks
Number of Participants Who Developed Anti-etelcalcetide Antibodies
Time Frame: Baseline, Week 12, Week 24, Week 36, Week 53, the 30-day follow-up visit
A validated dual flow-cell biosensor immunoassay was used to detect antibodies capable of binding etelcalcetide. The number of participants with a negative or no result at baseline and positive binding antibodies at any time post-baseline is reported.
Baseline, Week 12, Week 24, Week 36, Week 53, the 30-day follow-up visit
Change From Baseline in Blood Pressure
Time Frame: Baseline and Weeks 24 and 48
Blood pressure (BP) values were taken post-hemodialysis assessments.
Baseline and Weeks 24 and 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With > 30% Reduction From Baseline in PTH During the Efficacy Assessment Phase
Time Frame: Baseline and the efficacy assessment phase, defined as the last 6 weeks prior to ending treatment for participants who completed a minimum of 8 weeks of treatment (weeks 46-52 for participants who completed 52 weeks of treatment)
The efficacy assessment phase (EAP) is defined as the last 6 weeks before ending treatment, which was only for participants who completed a minimum of 8 weeks of treatment with etelcalcetide. If multiple assessments were available during the EAP, values were averaged.
Baseline and the efficacy assessment phase, defined as the last 6 weeks prior to ending treatment for participants who completed a minimum of 8 weeks of treatment (weeks 46-52 for participants who completed 52 weeks of treatment)
Percentage of Participants With > 30% Reduction From Baseline in PTH During the EAP12
Time Frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
The efficacy assessment phase at 12 months (EAP12) was defined as the period from week 46 to 53 (inclusive). If multiple assessments were available during the EAP12, values were averaged.
Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Percentage of Participants With PTH ≤ 300 pg/mL During the EAP
Time Frame: Baseline and the efficacy assessment phase
Baseline and the efficacy assessment phase
Percentage of Participants With PTH ≤ 300 pg/mL During the EAP12
Time Frame: Week 46 to 53
Week 46 to 53
Percent Change From Baseline in Mean PTH During the EAP
Time Frame: Baseline and the efficacy assessment phase
Baseline and the efficacy assessment phase
Percent Change From Baseline in Mean PTH During the EAP12
Time Frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Percent Change From Baseline in Mean Corrected Calcium During the EAP
Time Frame: Baseline and the efficacy assessment phase
Baseline and the efficacy assessment phase
Percent Change From Baseline in Mean Corrected Calcium During the EAP12
Time Frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP
Time Frame: Baseline and the efficacy assessment phase
Baseline and the efficacy assessment phase
Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP12
Time Frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Percent Change From Baseline in Mean Phosphorus During the EAP
Time Frame: Baseline and the efficacy assessment phase
Baseline and the efficacy assessment phase
Percent Change From Baseline in Mean Phosphorus During the EAP12
Time Frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Baseline and the efficacy assessment phase at month 12 (weeks 46-53)

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.

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)

July 31, 2013

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

July 1, 2015

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)

April 10, 2019

Last Update Submitted That Met QC Criteria

April 1, 2019

Last Verified

April 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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