Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis

Hyperparathyroidism, Secondary Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02102204
• Other study ID #: 20130213
• Secondary ID: 2013-004136-30KA
• Status: Completed
• Phase: Phase 3
• First received: March 3, 2014
• Last updated: October 18, 2017
• Start date: March 25, 2014
• Est. completion date: June 26, 2017

Study information

• Verified date: October 2017
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a multicenter, single-arm, extension study in which adults with secondary hyperparathyroidism currently receiving hemodialysis and previously treated in Amgen studies 20120231 (NCT01785875), 20120334 (NCT01576146), or 20120360 (NCT01896232) will continue to be treated with etelcalcetide until approximately 2.5 years after the first participant was enrolled.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 902
• Est. completion date: June 26, 2017
• Est. primary completion date: November 4, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Neoplasm Metastasis
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
Australia	Research Site	Adelaide	South Australia
Australia	Research Site	Brisbane	Queensland
Australia	Research Site	Clayton	Victoria
Australia	Research Site	Liverpool	New South Wales
Australia	Research Site	Prahan	Victoria
Australia	Research Site	Westmead	New South Wales
Austria	Research Site	Feldkirch
Austria	Research Site	Graz
Austria	Research Site	Linz
Austria	Research Site	Wien
Austria	Research Site	Wien
Belgium	Research Site	Aalst
Belgium	Research Site	Baudour
Belgium	Research Site	Bonheiden
Belgium	Research Site	Brussels
Belgium	Research Site	Bruxelles
Belgium	Research Site	Hasselt
Belgium	Research Site	Kortrijk
Belgium	Research Site	Leuven
Belgium	Research Site	Liege
Belgium	Research Site	Liège
Belgium	Research Site	Roeselare
Belgium	Research Site	Tournai
Canada	Research Site	Brampton	Ontario
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Greenfield Park	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Saint John	New Brunswick
Canada	Research Site	St. Johns	Newfoundland and Labrador
Czechia	Research Site	Hradec Kralove
Czechia	Research Site	Novy Jicin
Czechia	Research Site	Plzen
Czechia	Research Site	Praha 4
Czechia	Research Site	Praha 4 - Nusle
Czechia	Research Site	Praha 6
Czechia	Research Site	Slavkov u Brna
Czechia	Research Site	Usti nad Orlici
Denmark	Research Site	Fredericia
Denmark	Research Site	København
France	Research Site	Caen
France	Research Site	La Tronche cedex
France	Research Site	Lille Cedex
France	Research Site	Marseille
France	Research Site	Paris
France	Research Site	Paris
France	Research Site	Reims Cedex
France	Research Site	Saint Priest en Jarez
France	Research Site	Saint-Ouen
Germany	Research Site	Aachen
Germany	Research Site	Berlin
Germany	Research Site	Hamburg
Germany	Research Site	Langenhagen
Germany	Research Site	Minden
Germany	Research Site	München
Germany	Research Site	Villingen-Schwenningen
Germany	Research Site	Wiesbaden
Germany	Research Site	Zwickau
Greece	Research Site	Alexandroupoli
Greece	Research Site	Larissa
Greece	Research Site	Nikaia, Piraeus
Greece	Research Site	Patra
Greece	Research Site	Thessaloniki
Hungary	Research Site	Baja
Hungary	Research Site	Budapest
Hungary	Research Site	Esztergom
Hungary	Research Site	Gyor
Hungary	Research Site	Kaposvar
Hungary	Research Site	Kistarcsa
Hungary	Research Site	Miskolc
Hungary	Research Site	Pecs
Hungary	Research Site	Pecs
Hungary	Research Site	Szekesfehervar
Hungary	Research Site	Szigetvar
Hungary	Research Site	Zalaegerszeg
Israel	Research Site	Ashkelon
Israel	Research Site	Jerusalem
Israel	Research Site	Tel Aviv
Israel	Research Site	Tel Hashomer
Israel	Research Site	Zerifin
Italy	Research Site	Ancona
Italy	Research Site	Firenze
Italy	Research Site	Genova
Italy	Research Site	Lecco
Italy	Research Site	Lucca
Italy	Research Site	Milano
Italy	Research Site	Pavia
Italy	Research Site	Pisa
Italy	Research Site	Pordenone
Italy	Research Site	Verona
Latvia	Research Site	Riga
Lithuania	Research Site	Alytus
Lithuania	Research Site	Kaunas
Lithuania	Research Site	Kaunas
Lithuania	Research Site	Ukmerge
Netherlands	Research Site	Rotterdam
Netherlands	Research Site	Venlo
New Zealand	Research Site	Hamilton
Poland	Research Site	Gdansk
Poland	Research Site	Golub-Dobrzyn
Poland	Research Site	Katowice
Poland	Research Site	Krakow
Poland	Research Site	Lodz
Poland	Research Site	Poznan
Poland	Research Site	Poznan
Poland	Research Site	Sieradz
Poland	Research Site	Wadowice
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Zabrze
Poland	Research Site	Zamosc
Poland	Research Site	Zyrardow
Portugal	Research Site	Almada
Portugal	Research Site	Aveiro
Portugal	Research Site	Forte da Casa
Portugal	Research Site	Guimarães
Portugal	Research Site	Lisboa
Portugal	Research Site	Santo Tirso
Portugal	Research Site	Setubal
Portugal	Research Site	Vila Franca de Xira
Russian Federation	Research Site	Mitishi
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Petrozavodsk
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Yaroslavl
Spain	Research Site	Badajoz	Extremadura
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	Cordoba	Andalucía
Spain	Research Site	Lleida	Cataluña
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Majadahonda	Madrid
Spain	Research Site	Pamplona	Navarra
Spain	Research Site	Santander	Cantabria
Spain	Research Site	Torrevieja	Comunidad Valenciana
Spain	Research Site	Valencia	Comunidad Valenciana
Sweden	Research Site	Karlstad
Sweden	Research Site	Stockholm
Sweden	Research Site	Stockholm
Sweden	Research Site	Trollhättan
Sweden	Research Site	Uppsala
Switzerland	Research Site	Aarau
Switzerland	Research Site	Bern
Switzerland	Research Site	Geneva 14
Switzerland	Research Site	Lausanne
Switzerland	Research Site	Lausanne
Switzerland	Research Site	Locarno
Switzerland	Research Site	Zurich
Turkey	Research Site	Ankara
Turkey	Research Site	Ankara
Turkey	Research Site	Istanbul
Turkey	Research Site	Istanbul
Turkey	Research Site	Izmir
United States	Research Site	Alhambra	California
United States	Research Site	Arlington	Texas
United States	Research Site	Augusta	Georgia
United States	Research Site	Aurora	Colorado
United States	Research Site	Azusa	California
United States	Research Site	Bakersfield	California
United States	Research Site	Baton Rouge	Louisiana
United States	Research Site	Bethlehem	Pennsylvania
United States	Research Site	Birmingham	Alabama
United States	Research Site	Bluefield	West Virginia
United States	Research Site	Brookhaven	Mississippi
United States	Research Site	Brooklyn	New York
United States	Research Site	Burlington	Vermont
United States	Research Site	Chattanooga	Tennessee
United States	Research Site	Cincinnati	Ohio
United States	Research Site	College Point	New York
United States	Research Site	Columbia	South Carolina
United States	Research Site	Columbus	Ohio
United States	Research Site	Columbus	Mississippi
United States	Research Site	Cudahy	California
United States	Research Site	Detroit	Michigan
United States	Research Site	Dublin	Georgia
United States	Research Site	Durham	North Carolina
United States	Research Site	Eatontown	New Jersey
United States	Research Site	Edinburg	Texas
United States	Research Site	Fairfax	Virginia
United States	Research Site	Granada Hills	California
United States	Research Site	Great Neck	New York
United States	Research Site	Gulfport	Mississippi
United States	Research Site	Hampton	Virginia
United States	Research Site	Highland Park	Illinois
United States	Research Site	Houston	Texas
United States	Research Site	Kansas City	Missouri
United States	Research Site	Knoxville	Tennessee
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Los Angeles	California
United States	Research Site	Los Angeles	California
United States	Research Site	Mechanicsville	Virginia
United States	Research Site	Meridian	Idaho
United States	Research Site	Merrillville	Indiana
United States	Research Site	Miami	Florida
United States	Research Site	Michigan City	Indiana
United States	Research Site	Mineola	New York
United States	Research Site	New Bern	North Carolina
United States	Research Site	Northridge	California
United States	Research Site	Ocala	Florida
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pontiac	Michigan
United States	Research Site	Reno	Nevada
United States	Research Site	Riverside	California
United States	Research Site	Rosedale	New York
United States	Research Site	San Antonio	Texas
United States	Research Site	Simi Valley	California
United States	Research Site	Springfield	Massachusetts
United States	Research Site	Stamford	Connecticut
United States	Research Site	Tampa	Florida
United States	Research Site	The Bronx	New York
United States	Research Site	Tupelo	Mississippi
United States	Research Site	Vacaville	California
United States	Research Site	Voorhees	New Jersey
United States	Research Site	Westminster	Colorado
United States	Research Site	Whittier	California
United States	Research Site	Wichita	Kansas
United States	Research Site	Wilmington	North Carolina
United States	Research Site	Yonkers	New York

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Latvia,  Lithuania,  Netherlands,  New Zealand,  Poland,  Portugal,  Russian Federation,  Spain,  Sweden,  Switzerland,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events	A serious adverse event is an AE that met at least 1 of the following criteria: fatal; life threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect; other medically important serious event.; The relationship of each AE to study treatment was assessed by the investigator.; The following AE grading scale was used: Mild: Transient or mild discomfort; no limitation in activity; no medical intervention/therapy required Moderate: Mild to moderate limitation in activity-some assistance may be needed; no or minimal medical intervention/therapy required Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalization possible Life-threatening: Extreme limitation in activity, significant assistance required, significant medical intervention/therapy required, hospitalization probable.	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	Percentage of Participants With Parathyroid Hormone Levels Between Two to Nine-times the Upper Limit of Normal	The percentage of participants who maintained plasma parathyroid hormone (PTH) levels within the Kidney Disease Improving Global Outcomes (KDIGO) recommended range of not less than 2x the upper limit of normal (ULN) and not greater than 9x the ULN at months 6, 12, and 18, with the ULN based on the reference range of the assay used at the individual clinical site.	Months 6, 12, and 18
Secondary	Percentage of Participants With Serum Phosphorus = the ULN	Percentage of participants with serum phosphorus less than or equal to the upper limit of normal for the assay used.	Months 6, 12, and 18
Secondary	Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL	The percentage of participants with serum corrected calcium (cCa) reported for cumulative time intervals from day 1 through months 6, 12, and 18, using the participant's lowest recorded corrected calcium value during the time interval.; If serum albumin was less than 4.0 g/dL, serum calcium was corrected according to the following formula: cCa (mg/dL) = total calcium (mg/dL) + (4 - albumin [g/dL])*0.8. If serum albumin was > 4.0 g/dL no correction was made.	From day 1 to months 6, 12, and 18
Secondary	Number of Participants With Shifts From Baseline Grade 0 or 1 to Postbaseline Grade 3 or 4 for Laboratory Parameters	The Common Terminology Criteria for Adverse Events (CTCAE) grades for laboratory parameter values were defined based on the upper/lower limit of normal from the local laboratories contracted by the study centers.	Baseline to end of treatment; median duration of treatment was 563 days.
Secondary	Number of Participants Who Developed Positive Binding Anti-Etelcalcetide Antibodies	The number of participants who were binding antibody positive post-baseline with a negative or no result at baseline (where baseline for participants previously treated with etelcalcetide is Day 1 of the first study in which they were exposed to etelcalcetide and for participants previously treated with cinacalcet is the ending time point for study 20120360).	Baseline and every 6 months (up to 24 months)

External Links

•   AmgenTrials clinical trials website