Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
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
3 other identifiers
interventional
891
16 countries
201
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2013
201 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2013
CompletedFirst Posted
Study publicly available on registry
February 7, 2013
CompletedStudy Start
First participant enrolled
July 31, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
March 27, 2017
CompletedApril 10, 2019
April 1, 2019
1.9 years
February 5, 2013
February 7, 2017
April 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of Participants With Adverse Events (AEs)
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
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
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
Blood pressure (BP) values were taken post-hemodialysis assessments.
Baseline and Weeks 24 and 48
Secondary Outcomes (12)
Percentage of Participants With > 30% Reduction From Baseline in PTH During the Efficacy Assessment Phase
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
Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Percentage of Participants With PTH ≤ 300 pg/mL During the EAP
Baseline and the efficacy assessment phase
Percentage of Participants With PTH ≤ 300 pg/mL During the EAP12
Week 46 to 53
Percent Change From Baseline in Mean PTH During the EAP
Baseline and the efficacy assessment phase
- +7 more secondary outcomes
Study Arms (1)
Etelcalcetide
EXPERIMENTALParticipants 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (208)
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Birmingham, Alabama, 35211, United States
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Pine Bluff, Arkansas, 71603, United States
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Azusa, California, 91702, United States
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Bakersfield, California, 93308, United States
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Chula Vista, California, 91910, United States
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Cudahy, California, 90201, United States
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Fairfield, California, 94534, United States
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Glendale, California, 91205, United States
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Los Angeles, California, 90022, United States
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Los Angeles, California, 90025, United States
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Los Angeles, California, 90048, United States
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Lynwood, California, 90262, United States
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Northridge, California, 91324, United States
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Norwalk, California, 90650, United States
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Ontario, California, 91762, United States
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Riverside, California, 92501, United States
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San Gabriel, California, 91776, United States
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Simi Valley, California, 93065, United States
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Whittier, California, 90603, United States
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Arvada, Colorado, 80002, United States
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Denver, Colorado, 80230, United States
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Stamford, Connecticut, 06902, United States
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Coral Springs, Florida, 33071, United States
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Lauderdale Lakes, Florida, 33313, United States
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Miami, Florida, 33150, United States
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Miami, Florida, 33173, United States
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Ocala, Florida, 34471, United States
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Pembroke Pines, Florida, 33025, United States
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Pinecrest, Florida, 33156, United States
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Tampa, Florida, 33614, United States
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Augusta, Georgia, 30901, United States
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Macon, Georgia, 31217, United States
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Meridian, Idaho, 83642, United States
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Evanston, Illinois, 60201, United States
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Gurnee, Illinois, 60031, United States
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Merrillville, Indiana, 46410, United States
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Michigan City, Indiana, 46360, United States
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Wichita, Kansas, 67214-2998, United States
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Baton Rouge, Louisiana, 70808, United States
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Lafayette, Louisiana, 70503, United States
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Shreveport, Louisiana, 71101, United States
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Springfield, Massachusetts, 01107, United States
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Detroit, Michigan, 48202, United States
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Detroit, Michigan, 48236, United States
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Kalamazoo, Michigan, 49007, United States
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Pontiac, Michigan, 48341, United States
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Brookhaven, Mississippi, 39601, United States
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Columbus, Mississippi, 39705, United States
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Gulfport, Mississippi, 39501, United States
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Tupelo, Mississippi, 38801, United States
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Kansas City, Missouri, 64111, United States
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St Louis, Missouri, 63136, United States
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Lincoln, Nebraska, 68510, United States
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Las Vegas, Nevada, 89106, United States
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Reno, Nevada, 89511, United States
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Portsmouth, New Hampshire, 03801, United States
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Eatontown, New Jersey, 07724, United States
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Brooklyn, New York, 11212, United States
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Brooklyn, New York, 11235, United States
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Great Neck, New York, 11021, United States
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Orchard Park, New York, 14127, United States
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Ridgewood, New York, 11385, United States
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Rosedale, New York, 11422, United States
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The Bronx, New York, 10461, United States
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Yonkers, New York, 10704, United States
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Carrboro, North Carolina, 27510, United States
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Charlotte, North Carolina, 28207, United States
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Durham, North Carolina, 27704, United States
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New Bern, North Carolina, 28562, United States
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Cincinnati, Ohio, 45206, United States
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Oklahoma City, Oklahoma, 73116, United States
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Bethlehem, Pennsylvania, 18017, United States
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Philadelphia, Pennsylvania, 19106, United States
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Philadelphia, Pennsylvania, 19118, United States
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Columbia, South Carolina, 29203, United States
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Orangeburg, South Carolina, 29118, United States
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Chattanooga, Tennessee, 37408, United States
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Columbia, Tennessee, 38401, United States
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Knoxville, Tennessee, 37923, United States
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Nashville, Tennessee, 37205, United States
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Arlington, Texas, 76015, United States
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Austin, Texas, 78758, United States
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Edinburg, Texas, 78539, United States
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Fort Worth, Texas, 76104, United States
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Fort Worth, Texas, 76105, United States
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Fort Worth, Texas, 76164, United States
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Grand Prairie, Texas, 75050, United States
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Houston, Texas, 77004, United States
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Houston, Texas, 77054, United States
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Lubbock, Texas, 79430, United States
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Mansfield, Texas, 76063, United States
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San Antonio, Texas, 78205, United States
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San Antonio, Texas, 78215, United States
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San Antonio, Texas, 78229, United States
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Alexandria, Virginia, 22304, United States
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Alexandria, Virginia, 22306, United States
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Fairfax, Virginia, 22033, United States
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Hampton, Virginia, 23666, United States
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Mechanicsville, Virginia, 23116, United States
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Norfolk, Virginia, 23502, United States
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Bluefield, West Virginia, 24701, United States
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Liverpool, New South Wales, 2170, Australia
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St Leonards, New South Wales, 2065, Australia
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Westmead, New South Wales, 2145, Australia
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Brisbane, Queensland, 4102, Australia
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Adelaide, South Australia, 5000, Australia
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Clayton, Victoria, 3168, Australia
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Parkville, Victoria, 3050, Australia
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Graz, 8036, Austria
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Linz, 4010, Austria
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Vienna, 1090, Austria
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Aalst, 9300, Belgium
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Baudour, 7331, Belgium
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Bonheiden, 2820, Belgium
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Brussels, 1020, Belgium
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Brussels, 1090, Belgium
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Brussels, 1200, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Roeselare, 8800, Belgium
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Tournai, 7500, Belgium
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Edmonton, Alberta, T6G 2B7, Canada
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Brampton, Ontario, L6R 3J7, Canada
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Greenfield Park, Quebec, J4V 2H1, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Hradec Králové, 500 05, Czechia
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Nový Jičín, 741 01, Czechia
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Pilsen, 301 00, Czechia
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Prague, 140 21, Czechia
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Prague, 169 00, Czechia
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Praha 4 - Nusle, 140 00, Czechia
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Slavkov u Brna, 684 01, Czechia
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Ústí nad Orlicí, 562 18, Czechia
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Bordeaux, 33076, France
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Caen, 14000, France
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La Tronche, 38701, France
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Marseille, 13253, France
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Marseille, 13385, France
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Poitiers, 86021, France
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Reims, 51092, France
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Saint-Ouen, 93400, France
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Berlin, 12053, Germany
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Dresden, 01307, Germany
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Erfurt, 99089, Germany
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Villingen-Schwenningen, 78052, Germany
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Baja, 6500, Hungary
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Budapest, 1037, Hungary
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Budapest, 1076, Hungary
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Budapest, 1106, Hungary
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Esztergom, 2500, Hungary
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Győr, 9023, Hungary
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Kaposvár, 7400, Hungary
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Kecskemét, 6000, Hungary
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Miskolc, 3526, Hungary
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Pécs, 7624, Hungary
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Zalaegerszeg, 8900, Hungary
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Ashkelon, 78278, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 44281, Israel
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Nahariya, 22100, Israel
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Tel Aviv, 64239, Israel
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Tel Litwinsky, 52621, Israel
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Ẕerifin, 70300, Israel
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Ancona, 60131, Italy
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Lecco, 23900, Italy
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Milan, 20122, Italy
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Milan, 20142, Italy
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Pavia, 27100, Italy
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Verona, 37126, Italy
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Amsterdam, 1081 HV, Netherlands
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Enschede, 7511 JX, Netherlands
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Rotterdam, 3079 DZ, Netherlands
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Venlo, 5912 BL, Netherlands
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Bialystok, 15-540, Poland
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Gdansk, 80-952, Poland
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Golub-Dobrzyń, 87-400, Poland
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Krakow, 31-501, Poland
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Lodz, 90-153, Poland
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Rybnik, 44-200, Poland
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Warsaw, 02-006, Poland
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Warsaw, 02-097, Poland
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Warsaw, 04-749, Poland
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Zamość, 87-100, Poland
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Moscow, 123183, Russia
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Saint Petersburg, 191104, Russia
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Saint Petersburg, 195067, Russia
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Saint Petersburg, 195257, Russia
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Saint Petersburg, 196247, Russia
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Saint Petersburg, 197110, Russia
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Saint Petersburg, 198510, Russia
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Yaroslavl, 150062, Russia
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Córdoba, Andalusia, 14004, Spain
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Santander, Cantabria, 39008, Spain
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Barcelona, Catalonia, 08003, Spain
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Barcelona, Catalonia, 08025, Spain
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Barcelona, Catalonia, 08035, Spain
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Barcelona, Catalonia, 08036, Spain
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Majadahonda, Madrid, 28222, Spain
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Madrid, 28041, Spain
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Karlstad, 651 85, Sweden
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Stockholm, 141 86, Sweden
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Uppsala, 751 85, Sweden
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Cambridge, CB2 2QQ, United Kingdom
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Coventry, CV2 2DX, United Kingdom
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London, NW3 2QG, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Sheffield, S5 7AU, United Kingdom
Related Publications (2)
Block GA, Chertow GM, Sullivan JT, Deng H, Mather O, Tomlin H, Serenko M. An integrated analysis of safety and tolerability of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism. PLoS One. 2019 Mar 15;14(3):e0213774. doi: 10.1371/journal.pone.0213774. eCollection 2019.
PMID: 30875390BACKGROUNDBushinsky DA, Chertow GM, Cheng S, Deng H, Kopyt N, Martin KJ, Rastogi A, Urena-Torres P, Vervloet M, Block GA. One-year safety and efficacy of intravenous etelcalcetide in patients on hemodialysis with secondary hyperparathyroidism. Nephrol Dial Transplant. 2020 Oct 1;35(10):1769-1778. doi: 10.1093/ndt/gfz039.
PMID: 30859218DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2013
First Posted
February 7, 2013
Study Start
July 31, 2013
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
April 10, 2019
Results First Posted
March 27, 2017
Record last verified: 2019-04