Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease 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
508
14 countries
114
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2013
Shorter than P25 for phase_3
114 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
March 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2014
CompletedResults Posted
Study results publicly available
March 27, 2017
CompletedAugust 26, 2019
August 1, 2019
1.2 years
February 5, 2013
February 7, 2017
August 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With a > 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 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)
Etelcalcetide
EXPERIMENTALParticipants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times a week, for 26 weeks.
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.
Interventions
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.
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 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.
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 (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (118)
Research Site
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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Covina, California, 91723, United States
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Lakewood, California, 90712, United States
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Los Angeles, California, 90025, United States
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Lynwood, California, 90262, United States
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Northridge, California, 91324, United States
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Ontario, California, 91762, United States
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Panorama City, California, 91402, United States
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Sacramento, California, 95825, United States
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Whittier, California, 90603, United States
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Pembroke Pines, Florida, 33028, United States
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Meridian, Idaho, 83642, United States
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Evanston, Illinois, 60201, United States
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Springfield, Massachusetts, 01107, 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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Southgate, Michigan, 48195, 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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Reno, Nevada, 89511, United States
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Amherst, New York, 14226, United States
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Brooklyn, New York, 11235, 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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Chapel Hill, North Carolina, 27599, United States
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Durham, North Carolina, 27704, United States
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Allentown, Pennsylvania, 18104, United States
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Philadelphia, Pennsylvania, 19106, United States
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Philadelphia, Pennsylvania, 19118, United States
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Orangeburg, South Carolina, 29118, United States
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Sumter, South Carolina, 29150, United States
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Columbia, Tennessee, 38401, United States
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Nashville, Tennessee, 37205, United States
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Austin, Texas, 78758, 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, 77030, 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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Tyler, Texas, 75701, United States
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Fairfax, Virginia, 22033, 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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Parkville, Victoria, 3050, Australia
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Prahan, Victoria, 3004, 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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Brussels, 1020, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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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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Québec, Quebec, G1R 2J6, Canada
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Hradec Králové, 500 05, 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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Třinec, 739 61, Czechia
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Nantes, 44200, 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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Salouël, 80054, France
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Berlin, 12053, Germany
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Dresden, 01307, Germany
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Kiel, 24105, 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, 1115, Hungary
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Győr, 9023, Hungary
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Kaposvár, 7400, Hungary
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Pécs, 7624, Hungary
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Ashkelon, 78278, Israel
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Nahariya, 22100, Israel
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Tel Aviv, 64239, Israel
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Milan, 20122, Italy
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Napoli, 80131, Italy
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Pavia, 27100, Italy
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San Fermo Della Battaglia (CO), 22020, Italy
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Verona, 37126, Italy
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Bialystok, 15-540, Poland
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Warsaw, 02-006, Poland
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Warsaw, 02-097, Poland
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Warsaw, 04-141, Poland
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Wroclaw, 51-124, Poland
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Zamość, 87-100, Poland
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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, 198510, Russia
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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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Madrid, 28041, Spain
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Madrid, 28046, Spain
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Cambridge, CB2 2QQ, United Kingdom
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Coventry, CV2 2DX, United Kingdom
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Glasgow, G11 6NT, United Kingdom
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London, NW3 2QG, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Salford, M6 8HD, United Kingdom
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Sheffield, S5 7AU, United Kingdom
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 5, 2013
First Posted
February 7, 2013
Study Start
March 12, 2013
Primary Completion
May 22, 2014
Study Completion
June 12, 2014
Last Updated
August 26, 2019
Results First Posted
March 27, 2017
Record last verified: 2019-08