Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01785875
Registration number
NCT01785875
Ethics application status
Date submitted
5/02/2013
Date registered
7/02/2013
Date last updated
10/04/2019
Titles & IDs
Public title
Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
Query!
Scientific title
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
Query!
Secondary ID [1]
0
0
KAI-4169-008
Query!
Secondary ID [2]
0
0
20120231
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hyperparathyroidism, Secondary
0
0
Query!
Condition category
Condition code
Renal and Urogenital
0
0
0
0
Query!
Kidney disease
Query!
Renal and Urogenital
0
0
0
0
Query!
Other renal and urogenital disorders
Query!
Metabolic and Endocrine
0
0
0
0
Query!
Other endocrine disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Etelcalcetide
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.
Treatment: Drugs: Etelcalcetide
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).
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With Adverse Events (AEs)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
From first dose until 30 days after last dose; the treatment period was 52 weeks.
Query!
Primary outcome [2]
0
0
Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
52 weeks
Query!
Primary outcome [3]
0
0
Number of Participants Who Developed Anti-etelcalcetide Antibodies
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Baseline, Week 12, Week 24, Week 36, Week 53, the 30-day follow-up visit
Query!
Primary outcome [4]
0
0
Change From Baseline in Blood Pressure
Query!
Assessment method [4]
0
0
Blood pressure (BP) values were taken post-hemodialysis assessments.
Query!
Timepoint [4]
0
0
Baseline and Weeks 24 and 48
Query!
Secondary outcome [1]
0
0
Percentage of Participants With > 30% Reduction From Baseline in PTH During the Efficacy Assessment Phase
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
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)
Query!
Secondary outcome [2]
0
0
Percentage of Participants With > 30% Reduction From Baseline in PTH During the EAP12
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Query!
Secondary outcome [3]
0
0
Percentage of Participants With PTH = 300 pg/mL During the EAP
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Baseline and the efficacy assessment phase
Query!
Secondary outcome [4]
0
0
Percentage of Participants With PTH = 300 pg/mL During the EAP12
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Week 46 to 53
Query!
Secondary outcome [5]
0
0
Percent Change From Baseline in Mean PTH During the EAP
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Baseline and the efficacy assessment phase
Query!
Secondary outcome [6]
0
0
Percent Change From Baseline in Mean PTH During the EAP12
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Query!
Secondary outcome [7]
0
0
Percent Change From Baseline in Mean Corrected Calcium During the EAP
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
Baseline and the efficacy assessment phase
Query!
Secondary outcome [8]
0
0
Percent Change From Baseline in Mean Corrected Calcium During the EAP12
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Query!
Secondary outcome [9]
0
0
Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
Baseline and the efficacy assessment phase
Query!
Secondary outcome [10]
0
0
Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP12
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Query!
Secondary outcome [11]
0
0
Percent Change From Baseline in Mean Phosphorus During the EAP
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
Baseline and the efficacy assessment phase
Query!
Secondary outcome [12]
0
0
Percent Change From Baseline in Mean Phosphorus During the EAP12
Query!
Assessment method [12]
0
0
Query!
Timepoint [12]
0
0
Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Query!
Eligibility
Key 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
100
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
31/07/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/07/2015
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
891
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
Research Site - Liverpool
Query!
Recruitment hospital [2]
0
0
Research Site - St Leonards
Query!
Recruitment hospital [3]
0
0
Research Site - Westmead
Query!
Recruitment hospital [4]
0
0
Research Site - Brisbane
Query!
Recruitment hospital [5]
0
0
Research Site - Adelaide
Query!
Recruitment hospital [6]
0
0
Research Site - Clayton
Query!
Recruitment hospital [7]
0
0
Research Site - Parkville
Query!
Recruitment postcode(s) [1]
0
0
2170 - Liverpool
Query!
Recruitment postcode(s) [2]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [3]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [4]
0
0
4102 - Brisbane
Query!
Recruitment postcode(s) [5]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [6]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [7]
0
0
3050 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Idaho
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Illinois
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Indiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Kansas
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Louisiana
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Massachusetts
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Michigan
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Mississippi
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Missouri
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Nebraska
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Nevada
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New Hampshire
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New Jersey
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
New York
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
North Carolina
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Ohio
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Oklahoma
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Pennsylvania
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
South Carolina
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Tennessee
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Texas
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Virginia
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
West Virginia
Query!
Country [31]
0
0
Austria
Query!
State/province [31]
0
0
Graz
Query!
Country [32]
0
0
Austria
Query!
State/province [32]
0
0
Linz
Query!
Country [33]
0
0
Austria
Query!
State/province [33]
0
0
Wien
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Aalst
Query!
Country [35]
0
0
Belgium
Query!
State/province [35]
0
0
Baudour
Query!
Country [36]
0
0
Belgium
Query!
State/province [36]
0
0
Bonheiden
Query!
Country [37]
0
0
Belgium
Query!
State/province [37]
0
0
Brussels
Query!
Country [38]
0
0
Belgium
Query!
State/province [38]
0
0
Brussel
Query!
Country [39]
0
0
Belgium
Query!
State/province [39]
0
0
Bruxelles
Query!
Country [40]
0
0
Belgium
Query!
State/province [40]
0
0
Leuven
Query!
Country [41]
0
0
Belgium
Query!
State/province [41]
0
0
Liege
Query!
Country [42]
0
0
Belgium
Query!
State/province [42]
0
0
Liège
Query!
Country [43]
0
0
Belgium
Query!
State/province [43]
0
0
Roeselare
Query!
Country [44]
0
0
Belgium
Query!
State/province [44]
0
0
Tournai
Query!
Country [45]
0
0
Canada
Query!
State/province [45]
0
0
Alberta
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
Ontario
Query!
Country [47]
0
0
Canada
Query!
State/province [47]
0
0
Quebec
Query!
Country [48]
0
0
Czechia
Query!
State/province [48]
0
0
Hradec Kralove
Query!
Country [49]
0
0
Czechia
Query!
State/province [49]
0
0
Novy Jicin
Query!
Country [50]
0
0
Czechia
Query!
State/province [50]
0
0
Plzen
Query!
Country [51]
0
0
Czechia
Query!
State/province [51]
0
0
Praha 4 - Nusle
Query!
Country [52]
0
0
Czechia
Query!
State/province [52]
0
0
Praha 4
Query!
Country [53]
0
0
Czechia
Query!
State/province [53]
0
0
Praha 6
Query!
Country [54]
0
0
Czechia
Query!
State/province [54]
0
0
Slavkov u Brna
Query!
Country [55]
0
0
Czechia
Query!
State/province [55]
0
0
Usti nad Orlici
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Bordeaux Cedex
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Caen
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
La Tronche cedex
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Marseille cedex 5
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Marseille
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Poitiers
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Reims Cedex
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Saint-Ouen
Query!
Country [64]
0
0
Germany
Query!
State/province [64]
0
0
Berlin
Query!
Country [65]
0
0
Germany
Query!
State/province [65]
0
0
Dresden
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
Erfurt
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Villingen-Schwenningen
Query!
Country [68]
0
0
Hungary
Query!
State/province [68]
0
0
Baja
Query!
Country [69]
0
0
Hungary
Query!
State/province [69]
0
0
Budapest
Query!
Country [70]
0
0
Hungary
Query!
State/province [70]
0
0
Esztergom
Query!
Country [71]
0
0
Hungary
Query!
State/province [71]
0
0
Gyor
Query!
Country [72]
0
0
Hungary
Query!
State/province [72]
0
0
Kaposvar
Query!
Country [73]
0
0
Hungary
Query!
State/province [73]
0
0
Kecskemet
Query!
Country [74]
0
0
Hungary
Query!
State/province [74]
0
0
Miskolc
Query!
Country [75]
0
0
Hungary
Query!
State/province [75]
0
0
Pecs
Query!
Country [76]
0
0
Hungary
Query!
State/province [76]
0
0
Zalaegerszeg
Query!
Country [77]
0
0
Israel
Query!
State/province [77]
0
0
Ashkelon
Query!
Country [78]
0
0
Israel
Query!
State/province [78]
0
0
Jerusalem
Query!
Country [79]
0
0
Israel
Query!
State/province [79]
0
0
Kfar-Saba
Query!
Country [80]
0
0
Israel
Query!
State/province [80]
0
0
Nahariya
Query!
Country [81]
0
0
Israel
Query!
State/province [81]
0
0
Tel Aviv
Query!
Country [82]
0
0
Israel
Query!
State/province [82]
0
0
Tel Hashomer
Query!
Country [83]
0
0
Israel
Query!
State/province [83]
0
0
Zerifin
Query!
Country [84]
0
0
Italy
Query!
State/province [84]
0
0
Ancona
Query!
Country [85]
0
0
Italy
Query!
State/province [85]
0
0
Lecco
Query!
Country [86]
0
0
Italy
Query!
State/province [86]
0
0
Milano
Query!
Country [87]
0
0
Italy
Query!
State/province [87]
0
0
Pavia
Query!
Country [88]
0
0
Italy
Query!
State/province [88]
0
0
Verona
Query!
Country [89]
0
0
Netherlands
Query!
State/province [89]
0
0
Amsterdam
Query!
Country [90]
0
0
Netherlands
Query!
State/province [90]
0
0
Enschede
Query!
Country [91]
0
0
Netherlands
Query!
State/province [91]
0
0
Rotterdam
Query!
Country [92]
0
0
Netherlands
Query!
State/province [92]
0
0
Venlo
Query!
Country [93]
0
0
Poland
Query!
State/province [93]
0
0
Bialystok
Query!
Country [94]
0
0
Poland
Query!
State/province [94]
0
0
Gdansk
Query!
Country [95]
0
0
Poland
Query!
State/province [95]
0
0
Golub-Dobrzyn
Query!
Country [96]
0
0
Poland
Query!
State/province [96]
0
0
Krakow
Query!
Country [97]
0
0
Poland
Query!
State/province [97]
0
0
Lodz
Query!
Country [98]
0
0
Poland
Query!
State/province [98]
0
0
Rybnik
Query!
Country [99]
0
0
Poland
Query!
State/province [99]
0
0
Warszawa
Query!
Country [100]
0
0
Poland
Query!
State/province [100]
0
0
Zamosc
Query!
Country [101]
0
0
Russian Federation
Query!
State/province [101]
0
0
Moscow
Query!
Country [102]
0
0
Russian Federation
Query!
State/province [102]
0
0
Saint Petersburg
Query!
Country [103]
0
0
Russian Federation
Query!
State/province [103]
0
0
Saint-Petersburg
Query!
Country [104]
0
0
Russian Federation
Query!
State/province [104]
0
0
Yaroslavl
Query!
Country [105]
0
0
Spain
Query!
State/province [105]
0
0
Andalucía
Query!
Country [106]
0
0
Spain
Query!
State/province [106]
0
0
Cantabria
Query!
Country [107]
0
0
Spain
Query!
State/province [107]
0
0
Cataluña
Query!
Country [108]
0
0
Spain
Query!
State/province [108]
0
0
Madrid
Query!
Country [109]
0
0
Sweden
Query!
State/province [109]
0
0
Karlstad
Query!
Country [110]
0
0
Sweden
Query!
State/province [110]
0
0
Stockholm
Query!
Country [111]
0
0
Sweden
Query!
State/province [111]
0
0
Uppsala
Query!
Country [112]
0
0
United Kingdom
Query!
State/province [112]
0
0
Cambridge
Query!
Country [113]
0
0
United Kingdom
Query!
State/province [113]
0
0
Coventry
Query!
Country [114]
0
0
United Kingdom
Query!
State/province [114]
0
0
London
Query!
Country [115]
0
0
United Kingdom
Query!
State/province [115]
0
0
Nottingham
Query!
Country [116]
0
0
United Kingdom
Query!
State/province [116]
0
0
Sheffield
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Amgen
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01785875
Query!
Trial related presentations / publications
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. Bushinsky 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. Erratum In: Nephrol Dial Transplant. 2019 May 15:1642. doi: 10.1093/ndt/gfz111.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
MD
Query!
Address
0
0
Amgen
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
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/NCT01785875
Download to PDF