Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02102204




Registration number
NCT02102204
Ethics application status
Date submitted
3/03/2014
Date registered
2/04/2014
Date last updated
17/11/2017

Titles & IDs
Public title
Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis
Scientific title
A Multicenter Single-arm Extension Study to Describe the Long-term Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis
Secondary ID [1] 0 0
2013-004136-30
Secondary ID [2] 0 0
20130213
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperparathyroidism, Secondary 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Etelcalcetide

Experimental: Etelcalcetide - Participants received etelcalcetide three times a week (TIW) by bolus injection at the end of hemodialysis. The minimum etelcalcetide dose in this study was 2.5 mg and the maximum dose was 15 mg. Etelcalcetide dose was titrated to maintain parathyroid hormone levels within 2x to 9x the upper limit of normal based on the reference range of the assay used at the individual study center.


Treatment: Drugs: Etelcalcetide
Etelcalcetide was supplied as a sterile, preservative-free, ready-to-administer aqueous solution.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events
Timepoint [1] 0 0
From the date of first dose of etelcalcetide (in the current study) and up to 30 days after the last dose; median duration of treatment was 563 days.
Secondary outcome [1] 0 0
Percentage of Participants With Parathyroid Hormone Levels Between Two to Nine-times the Upper Limit of Normal
Timepoint [1] 0 0
Months 6, 12, and 18
Secondary outcome [2] 0 0
Percentage of Participants With Serum Phosphorus = the ULN
Timepoint [2] 0 0
Months 6, 12, and 18
Secondary outcome [3] 0 0
Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL
Timepoint [3] 0 0
From day 1 to months 6, 12, and 18
Secondary outcome [4] 0 0
Number of Participants With Shifts From Baseline Grade 0 or 1 to Postbaseline Grade 3 or 4 for Laboratory Parameters
Timepoint [4] 0 0
Baseline to end of treatment; median duration of treatment was 563 days.
Secondary outcome [5] 0 0
Number of Participants Who Developed Positive Binding Anti-Etelcalcetide Antibodies
Timepoint [5] 0 0
Baseline and every 6 months (up to 24 months)

Eligibility
Key inclusion criteria
* Subject has provided informed consent prior to initiation of any study-specific activities/procedures
* Subject has completed treatment in Study 20120231 (also known as KAI-4169-008) or Study 20120360, or has participated in Study 20120334 (also known as KAI-4169-005-01)
* Female subjects who are: post-menopausal (post-menopausal is defined as no menses for the previous 1 year and over the age of 50 years), surgically sterilized, have a medical condition that prevents pregnancy, remain abstinent, or are willing to use an acceptable method of effective contraception during the study and for 3 months after the last dose. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 2 weeks prior to the first dose of AMG 416 in the current study
* Subject must be receiving hemodialysis 3 or 4 times weekly for at least 3 months
Minimum age
18 Years
Maximum age
110 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Currently receiving treatment in another investigational device or drug study (other than in one of the designated parent studies)
* Subject has known sensitivity to any of the products or components to be administered during dosing
* Subject has been prescribed cinacalcet by the primary nephrologist between the conclusion of the parent study and the start of dosing with AMG 416 in the current study
* Subject is receiving dialysis prescription dialysate calcium concentration < 2.25 mEq/L
* Subject is pregnant or nursing

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Research Site - Liverpool
Recruitment hospital [2] 0 0
Research Site - Westmead
Recruitment hospital [3] 0 0
Research Site - Brisbane
Recruitment hospital [4] 0 0
Research Site - Adelaide
Recruitment hospital [5] 0 0
Research Site - Clayton
Recruitment hospital [6] 0 0
Research Site - Prahan
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4102 - Brisbane
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3004 - Prahan
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Mississippi
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Nebraska
Country [17] 0 0
United States of America
State/province [17] 0 0
Nevada
Country [18] 0 0
United States of America
State/province [18] 0 0
New Jersey
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Oklahoma
Country [23] 0 0
United States of America
State/province [23] 0 0
Pennsylvania
Country [24] 0 0
United States of America
State/province [24] 0 0
South Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Tennessee
Country [26] 0 0
United States of America
State/province [26] 0 0
Texas
Country [27] 0 0
United States of America
State/province [27] 0 0
Vermont
Country [28] 0 0
United States of America
State/province [28] 0 0
Virginia
Country [29] 0 0
United States of America
State/province [29] 0 0
West Virginia
Country [30] 0 0
Austria
State/province [30] 0 0
Feldkirch
Country [31] 0 0
Austria
State/province [31] 0 0
Graz
Country [32] 0 0
Austria
State/province [32] 0 0
Linz
Country [33] 0 0
Austria
State/province [33] 0 0
Wien
Country [34] 0 0
Belgium
State/province [34] 0 0
Aalst
Country [35] 0 0
Belgium
State/province [35] 0 0
Baudour
Country [36] 0 0
Belgium
State/province [36] 0 0
Bonheiden
Country [37] 0 0
Belgium
State/province [37] 0 0
Brussels
Country [38] 0 0
Belgium
State/province [38] 0 0
Bruxelles
Country [39] 0 0
Belgium
State/province [39] 0 0
Hasselt
Country [40] 0 0
Belgium
State/province [40] 0 0
Kortrijk
Country [41] 0 0
Belgium
State/province [41] 0 0
Leuven
Country [42] 0 0
Belgium
State/province [42] 0 0
Liege
Country [43] 0 0
Belgium
State/province [43] 0 0
Liège
Country [44] 0 0
Belgium
State/province [44] 0 0
Roeselare
Country [45] 0 0
Belgium
State/province [45] 0 0
Tournai
Country [46] 0 0
Canada
State/province [46] 0 0
Alberta
Country [47] 0 0
Canada
State/province [47] 0 0
New Brunswick
Country [48] 0 0
Canada
State/province [48] 0 0
Newfoundland and Labrador
Country [49] 0 0
Canada
State/province [49] 0 0
Ontario
Country [50] 0 0
Canada
State/province [50] 0 0
Quebec
Country [51] 0 0
Czechia
State/province [51] 0 0
Hradec Kralove
Country [52] 0 0
Czechia
State/province [52] 0 0
Novy Jicin
Country [53] 0 0
Czechia
State/province [53] 0 0
Plzen
Country [54] 0 0
Czechia
State/province [54] 0 0
Praha 4 - Nusle
Country [55] 0 0
Czechia
State/province [55] 0 0
Praha 4
Country [56] 0 0
Czechia
State/province [56] 0 0
Praha 6
Country [57] 0 0
Czechia
State/province [57] 0 0
Slavkov u Brna
Country [58] 0 0
Czechia
State/province [58] 0 0
Usti nad Orlici
Country [59] 0 0
Denmark
State/province [59] 0 0
Fredericia
Country [60] 0 0
Denmark
State/province [60] 0 0
København
Country [61] 0 0
France
State/province [61] 0 0
Caen
Country [62] 0 0
France
State/province [62] 0 0
La Tronche cedex
Country [63] 0 0
France
State/province [63] 0 0
Lille Cedex
Country [64] 0 0
France
State/province [64] 0 0
Marseille
Country [65] 0 0
France
State/province [65] 0 0
Paris
Country [66] 0 0
France
State/province [66] 0 0
Reims Cedex
Country [67] 0 0
France
State/province [67] 0 0
Saint Priest en Jarez
Country [68] 0 0
France
State/province [68] 0 0
Saint-Ouen
Country [69] 0 0
Germany
State/province [69] 0 0
Aachen
Country [70] 0 0
Germany
State/province [70] 0 0
Berlin
Country [71] 0 0
Germany
State/province [71] 0 0
Hamburg
Country [72] 0 0
Germany
State/province [72] 0 0
Langenhagen
Country [73] 0 0
Germany
State/province [73] 0 0
Minden
Country [74] 0 0
Germany
State/province [74] 0 0
München
Country [75] 0 0
Germany
State/province [75] 0 0
Villingen-Schwenningen
Country [76] 0 0
Germany
State/province [76] 0 0
Wiesbaden
Country [77] 0 0
Germany
State/province [77] 0 0
Zwickau
Country [78] 0 0
Greece
State/province [78] 0 0
Alexandroupoli
Country [79] 0 0
Greece
State/province [79] 0 0
Larissa
Country [80] 0 0
Greece
State/province [80] 0 0
Nikaia, Piraeus
Country [81] 0 0
Greece
State/province [81] 0 0
Patra
Country [82] 0 0
Greece
State/province [82] 0 0
Thessaloniki
Country [83] 0 0
Hungary
State/province [83] 0 0
Baja
Country [84] 0 0
Hungary
State/province [84] 0 0
Budapest
Country [85] 0 0
Hungary
State/province [85] 0 0
Esztergom
Country [86] 0 0
Hungary
State/province [86] 0 0
Gyor
Country [87] 0 0
Hungary
State/province [87] 0 0
Kaposvar
Country [88] 0 0
Hungary
State/province [88] 0 0
Kistarcsa
Country [89] 0 0
Hungary
State/province [89] 0 0
Miskolc
Country [90] 0 0
Hungary
State/province [90] 0 0
Pecs
Country [91] 0 0
Hungary
State/province [91] 0 0
Szekesfehervar
Country [92] 0 0
Hungary
State/province [92] 0 0
Szigetvar
Country [93] 0 0
Hungary
State/province [93] 0 0
Zalaegerszeg
Country [94] 0 0
Israel
State/province [94] 0 0
Ashkelon
Country [95] 0 0
Israel
State/province [95] 0 0
Jerusalem
Country [96] 0 0
Israel
State/province [96] 0 0
Tel Aviv
Country [97] 0 0
Israel
State/province [97] 0 0
Tel Hashomer
Country [98] 0 0
Israel
State/province [98] 0 0
Zerifin
Country [99] 0 0
Italy
State/province [99] 0 0
Ancona
Country [100] 0 0
Italy
State/province [100] 0 0
Firenze
Country [101] 0 0
Italy
State/province [101] 0 0
Genova
Country [102] 0 0
Italy
State/province [102] 0 0
Lecco
Country [103] 0 0
Italy
State/province [103] 0 0
Lucca
Country [104] 0 0
Italy
State/province [104] 0 0
Milano
Country [105] 0 0
Italy
State/province [105] 0 0
Pavia
Country [106] 0 0
Italy
State/province [106] 0 0
Pisa
Country [107] 0 0
Italy
State/province [107] 0 0
Pordenone
Country [108] 0 0
Italy
State/province [108] 0 0
Verona
Country [109] 0 0
Latvia
State/province [109] 0 0
Riga
Country [110] 0 0
Lithuania
State/province [110] 0 0
Alytus
Country [111] 0 0
Lithuania
State/province [111] 0 0
Kaunas
Country [112] 0 0
Lithuania
State/province [112] 0 0
Ukmerge
Country [113] 0 0
Netherlands
State/province [113] 0 0
Rotterdam
Country [114] 0 0
Netherlands
State/province [114] 0 0
Venlo
Country [115] 0 0
New Zealand
State/province [115] 0 0
Hamilton
Country [116] 0 0
Poland
State/province [116] 0 0
Gdansk
Country [117] 0 0
Poland
State/province [117] 0 0
Golub-Dobrzyn
Country [118] 0 0
Poland
State/province [118] 0 0
Katowice
Country [119] 0 0
Poland
State/province [119] 0 0
Krakow
Country [120] 0 0
Poland
State/province [120] 0 0
Lodz
Country [121] 0 0
Poland
State/province [121] 0 0
Poznan
Country [122] 0 0
Poland
State/province [122] 0 0
Sieradz
Country [123] 0 0
Poland
State/province [123] 0 0
Wadowice
Country [124] 0 0
Poland
State/province [124] 0 0
Warszawa
Country [125] 0 0
Poland
State/province [125] 0 0
Zabrze
Country [126] 0 0
Poland
State/province [126] 0 0
Zamosc
Country [127] 0 0
Poland
State/province [127] 0 0
Zyrardow
Country [128] 0 0
Portugal
State/province [128] 0 0
Almada
Country [129] 0 0
Portugal
State/province [129] 0 0
Aveiro
Country [130] 0 0
Portugal
State/province [130] 0 0
Forte da Casa
Country [131] 0 0
Portugal
State/province [131] 0 0
Guimarães
Country [132] 0 0
Portugal
State/province [132] 0 0
Lisboa
Country [133] 0 0
Portugal
State/province [133] 0 0
Santo Tirso
Country [134] 0 0
Portugal
State/province [134] 0 0
Setubal
Country [135] 0 0
Portugal
State/province [135] 0 0
Vila Franca de Xira
Country [136] 0 0
Russian Federation
State/province [136] 0 0
Mitishi
Country [137] 0 0
Russian Federation
State/province [137] 0 0
Moscow
Country [138] 0 0
Russian Federation
State/province [138] 0 0
Petrozavodsk
Country [139] 0 0
Russian Federation
State/province [139] 0 0
Saint Petersburg
Country [140] 0 0
Russian Federation
State/province [140] 0 0
Saint-Petersburg
Country [141] 0 0
Russian Federation
State/province [141] 0 0
Yaroslavl
Country [142] 0 0
Spain
State/province [142] 0 0
Andalucía
Country [143] 0 0
Spain
State/province [143] 0 0
Cantabria
Country [144] 0 0
Spain
State/province [144] 0 0
Cataluña
Country [145] 0 0
Spain
State/province [145] 0 0
Comunidad Valenciana
Country [146] 0 0
Spain
State/province [146] 0 0
Extremadura
Country [147] 0 0
Spain
State/province [147] 0 0
Madrid
Country [148] 0 0
Spain
State/province [148] 0 0
Navarra
Country [149] 0 0
Sweden
State/province [149] 0 0
Karlstad
Country [150] 0 0
Sweden
State/province [150] 0 0
Stockholm
Country [151] 0 0
Sweden
State/province [151] 0 0
Trollhättan
Country [152] 0 0
Sweden
State/province [152] 0 0
Uppsala
Country [153] 0 0
Switzerland
State/province [153] 0 0
Aarau
Country [154] 0 0
Switzerland
State/province [154] 0 0
Bern
Country [155] 0 0
Switzerland
State/province [155] 0 0
Geneva 14
Country [156] 0 0
Switzerland
State/province [156] 0 0
Lausanne
Country [157] 0 0
Switzerland
State/province [157] 0 0
Locarno
Country [158] 0 0
Switzerland
State/province [158] 0 0
Zurich
Country [159] 0 0
Turkey
State/province [159] 0 0
Ankara
Country [160] 0 0
Turkey
State/province [160] 0 0
Istanbul
Country [161] 0 0
Turkey
State/province [161] 0 0
Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on hemodialysis.
Trial website
https://clinicaltrials.gov/study/NCT02102204
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02102204