Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
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
3 other identifiers
interventional
515
15 countries
106
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2013
Shorter than P25 for phase_3
106 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 7, 2013
CompletedFirst Posted
Study publicly available on registry
February 11, 2013
CompletedStudy Start
First participant enrolled
March 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 9, 2014
CompletedResults Posted
Study results publicly available
March 27, 2017
CompletedAugust 20, 2019
August 1, 2019
1.1 years
February 7, 2013
February 7, 2017
August 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase
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 Outcomes (5)
Percentage of Participants With Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase
Baseline and the efficacy assessment phase (Week 20 to Week 27)
Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase
Baseline and the Efficacy Assessment Phase (Week 20 to Week 27)
Percent Change From Baseline in Predialysis Corrected Calcium During the Efficacy Assessment Phase
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
Baseline and the efficacy assessment phase (Week 20 to Week 27)
Percent Change From Baseline in Predialysis Phosphorus During the Efficacy Assessment Phase
Baseline and the efficacy assessment phase (Week 20 to Week 27)
Study Arms (2)
Placebo
PLACEBO COMPARATORParticipants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
Etelcalcetide
EXPERIMENTALParticipants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (106)
Research Site
Mobile, Alabama, 36608, United States
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Azusa, California, 91702, United States
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Beverly Hills, California, 90211, United States
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Chula Vista, California, 91910, 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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Northridge, California, 91324, United States
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Norwalk, California, 90650, United States
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Riverside, California, 92501, United States
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Simi Valley, California, 93065, United States
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Denver, Colorado, 80230, United States
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Stamford, Connecticut, 06902, United States
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Lauderdale Lakes, Florida, 33313, United States
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Miami, Florida, 33173, United States
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Ocala, Florida, 34471, United States
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Augusta, Georgia, 30901, United States
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Macon, Georgia, 31217, United States
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Chicago, Illinois, 60616, United States
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Gurnee, Illinois, 60031, United States
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Merrillville, Indiana, 46410, United States
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Wichita, Kansas, 67214-2998, United States
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Shreveport, Louisiana, 71101, United States
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Bethesda, Maryland, 20817, United States
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Ft. Washington, Maryland, 20744, United States
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Detroit, Michigan, 48202, United States
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Brookhaven, Mississippi, 39601, 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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Eatontown, New Jersey, 07724, United States
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Brooklyn, New York, 11212, United States
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Fresh Meadows, New York, 11365, United States
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Great Neck, New York, 11021, United States
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Charlotte, North Carolina, 28207, 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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Columbia, South Carolina, 29203, United States
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Chattanooga, Tennessee, 37408, United States
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Knoxville, Tennessee, 37923, United States
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Arlington, Texas, 76015, United States
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Houston, Texas, 77054, United States
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Lubbock, Texas, 79430, United States
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Rutland, Vermont, 05701, United States
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Alexandria, Virginia, 22304, United States
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Morgantown, West Virginia, 26506-9165, United States
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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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Bonheiden, 2820, Belgium
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Brussels, 1090, Belgium
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Brussels, 1200, 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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New Westminster, British Columbia, V3L 0A6, Canada
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Halifax, Nova Scotia, B3H 1V7, Canada
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Toronto, Ontario, M5C 2T2, Canada
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Montreal, Quebec, H4J 1C5, Canada
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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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Ústí nad Orlicí, 562 18, Czechia
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Bordeaux, 33075, France
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Caen, 14000, France
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Grenoble, 38000, France
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Marseille, 13253, France
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Marseille, 13385, France
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Perpignan, 66046, France
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Erfurt, 99089, Germany
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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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Kecskemét, 6000, Hungary
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Miskolc, 3526, Hungary
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Zalaegerszeg, 8900, Hungary
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Jerusalem, 91120, Israel
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Kfar Saba, 44281, 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, 20142, Italy
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Quartu Sant'Elena CA, 09045, 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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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, 04-749, Poland
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Moscow, 123183, Russia
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Saint Petersburg, 197110, Russia
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Yaroslavl, 150062, Russia
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Córdoba, Andalusia, 14004, Spain
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Granada, Andalusia, 18012, 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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Karlstad, 651 85, Sweden
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Stockholm, 141 86, Sweden
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Uppsala, 751 85, Sweden
Related Publications (9)
Block GA, Bushinsky DA, Cunningham J, Drueke TB, Ketteler M, Kewalramani R, Martin KJ, Mix TC, Moe SM, Patel UD, Silver J, Spiegel DM, Sterling L, Walsh L, Chertow GM. Effect of Etelcalcetide vs Placebo on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: Two Randomized Clinical Trials. JAMA. 2017 Jan 10;317(2):146-155. doi: 10.1001/jama.2016.19456.
PMID: 28097355BACKGROUNDKroenke MA, Weeraratne DK, Deng H, Sloey B, Subramanian R, Wu B, Serenko M, Hock MB. Clinical immunogenicity of the d-amino acid peptide therapeutic etelcalcetide: Method development challenges and anti-drug antibody clinical impact assessments. J Immunol Methods. 2017 Jun;445:37-44. doi: 10.1016/j.jim.2017.03.005. Epub 2017 Mar 6.
PMID: 28274835BACKGROUNDStollenwerk B, Iannazzo S, Akehurst R, Adena M, Briggs A, Dehmel B, Parfrey P, Belozeroff V. A Decision-Analytic Model to Assess the Cost-Effectiveness of Etelcalcetide vs. Cinacalcet. Pharmacoeconomics. 2018 May;36(5):603-612. doi: 10.1007/s40273-017-0605-2.
PMID: 29392552BACKGROUNDStollenwerk B, Iannazzo S, Cooper K, Belozeroff V. Exploring the potential value of improved care for secondary hyperparathyroidism with a novel calcimimetic therapy. J Med Econ. 2017 Oct;20(10):1110-1115. doi: 10.1080/13696998.2017.1360309. Epub 2017 Aug 14.
PMID: 28803497BACKGROUNDChen P, Narayanan A, Wu B, Gisleskog PO, Gibbs JP, Chow AT, Melhem M. Population Pharmacokinetic and Pharmacodynamic Modeling of Etelcalcetide in Patients with Chronic Kidney Disease and Secondary Hyperparathyroidism Receiving Hemodialysis. Clin Pharmacokinet. 2018 Jan;57(1):71-85. doi: 10.1007/s40262-017-0550-4.
PMID: 28508378BACKGROUNDBlock 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: 30875390BACKGROUNDCunningham J, Block GA, Chertow GM, Cooper K, Evenepoel P, Iles J, Sun Y, Urena-Torres P, Bushinsky DA. Etelcalcetide Is Effective at All Levels of Severity of Secondary Hyperparathyroidism in Hemodialysis Patients. Kidney Int Rep. 2019 Apr 16;4(7):987-994. doi: 10.1016/j.ekir.2019.04.010. eCollection 2019 Jul.
PMID: 31317120BACKGROUNDWolf M, Block GA, Chertow GM, Cooper K, Fouqueray B, Moe SM, Sun Y, Tomlin H, Vervloet M, Oberbauer R. Effects of etelcalcetide on fibroblast growth factor 23 in patients with secondary hyperparathyroidism receiving hemodialysis. Clin Kidney J. 2019 Apr 26;13(1):75-84. doi: 10.1093/ckj/sfz034. eCollection 2020 Feb.
PMID: 32082556BACKGROUNDHain D, Tomlin H, Gibson C. Administration of Etelcalcetide for the Treatment of Secondary Hyperparathyroidism in Patients with CKD-MBD on Hemodialysis: A Nephrology Nursing Perspective. Nephrol Nurs J. 2019 May-Jun;46(3):315-290.
PMID: 31199098BACKGROUND
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
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2013
First Posted
February 11, 2013
Study Start
March 12, 2013
Primary Completion
April 14, 2014
Study Completion
May 9, 2014
Last Updated
August 20, 2019
Results First Posted
March 27, 2017
Record last verified: 2019-08