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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01788046
Registration number
NCT01788046
Ethics application status
Date submitted
7/02/2013
Date registered
11/02/2013
Date last updated
20/08/2019
Titles & IDs
Public title
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
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Scientific title
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
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Secondary ID [1]
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KAI-4169-007
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Secondary ID [2]
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20120230
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hyperparathyroidism, Secondary
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Renal and Urogenital
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Other renal and urogenital disorders
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Metabolic and Endocrine
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Other endocrine disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Etelcalcetide
Treatment: Drugs - Placebo
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.
Experimental: Etelcalcetide - Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
Treatment: Drugs: Etelcalcetide
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.
Treatment: Drugs: Placebo
Administered intravenously (IV) three times per week.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase
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Assessment method [1]
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Participants who did not have any scheduled assessments during the EAP were considered non-responders.
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Timepoint [1]
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Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).
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Secondary outcome [1]
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Percentage of Participants With Mean Predialysis Parathyroid Hormone = 300 pg/mL During the Efficacy Assessment Phase
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Assessment method [1]
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Participants who had no scheduled assessments during the EAP were considered non-responders.
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Timepoint [1]
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Baseline and the efficacy assessment phase (Week 20 to Week 27)
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Secondary outcome [2]
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Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase
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Assessment method [2]
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Timepoint [2]
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Baseline and the Efficacy Assessment Phase (Week 20 to Week 27)
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Secondary outcome [3]
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Percent Change From Baseline in Predialysis Corrected Calcium During the Efficacy Assessment Phase
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Assessment method [3]
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Timepoint [3]
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Baseline and the efficacy assessment phase (Week 20 to Week 27)
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Secondary outcome [4]
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Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product (cCa x P) During the Efficacy Assessment Phase
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Assessment method [4]
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Timepoint [4]
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Baseline and the efficacy assessment phase (Week 20 to Week 27)
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Secondary outcome [5]
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Percent Change From Baseline in Predialysis Phosphorus During the Efficacy Assessment Phase
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Assessment method [5]
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Timepoint [5]
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Baseline and the efficacy assessment phase (Week 20 to Week 27)
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Eligibility
Key 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 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
* Other Inclusion Criteria may apply
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Minimum age
18
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Maximum age
100
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
* 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.
* Other Exclusion Criteria may apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/03/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/05/2014
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Sample size
Target
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Accrual to date
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Final
515
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Research Site - Clayton
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2145 - Westmead
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4102 - Brisbane
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5000 - Adelaide
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Recruitment postcode(s) [4]
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3168 - Clayton
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Primary sponsor type
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Name
Amgen
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT01788046
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Trial related presentations / publications
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. Kroenke 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. Stollenwerk 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. Stollenwerk 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. Chen 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. 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. Cunningham 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. Wolf 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. Hain 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.
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Public notes
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Contacts
Principal investigator
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MD
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Amgen
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01788046
Download to PDF