Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

Hyperparathyroidism, Secondary Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01785875
• Other study ID #: 20120231
• Secondary ID: KAI-4169-0082012
• Status: Completed
• Phase: Phase 3
• Start date: July 31, 2013
• Est. completion date: July 1, 2015

Study information

• Verified date: April 2019
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 891
• Est. completion date: July 1, 2015
• Est. primary completion date: July 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• 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).

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	Parkville	Victoria
Australia	Research Site	St Leonards	New South Wales
Australia	Research Site	Westmead	New South Wales
Austria	Research Site	Graz
Austria	Research Site	Linz
Austria	Research Site	Wien
Belgium	Research Site	Aalst
Belgium	Research Site	Baudour
Belgium	Research Site	Bonheiden
Belgium	Research Site	Brussel
Belgium	Research Site	Brussels
Belgium	Research Site	Bruxelles
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	Montreal	Quebec
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
France	Research Site	Bordeaux Cedex
France	Research Site	Caen
France	Research Site	La Tronche cedex
France	Research Site	Marseille
France	Research Site	Marseille cedex 5
France	Research Site	Poitiers
France	Research Site	Reims Cedex
France	Research Site	Saint-Ouen
Germany	Research Site	Berlin
Germany	Research Site	Dresden
Germany	Research Site	Erfurt
Germany	Research Site	Villingen-Schwenningen
Hungary	Research Site	Baja
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Esztergom
Hungary	Research Site	Gyor
Hungary	Research Site	Kaposvar
Hungary	Research Site	Kecskemet
Hungary	Research Site	Miskolc
Hungary	Research Site	Pecs
Hungary	Research Site	Zalaegerszeg
Israel	Research Site	Ashkelon
Israel	Research Site	Jerusalem
Israel	Research Site	Kfar-Saba
Israel	Research Site	Nahariya
Israel	Research Site	Tel Aviv
Israel	Research Site	Tel Hashomer
Israel	Research Site	Zerifin
Italy	Research Site	Ancona
Italy	Research Site	Lecco
Italy	Research Site	Milano
Italy	Research Site	Milano
Italy	Research Site	Pavia
Italy	Research Site	Verona
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Enschede
Netherlands	Research Site	Rotterdam
Netherlands	Research Site	Venlo
Poland	Research Site	Bialystok
Poland	Research Site	Gdansk
Poland	Research Site	Golub-Dobrzyn
Poland	Research Site	Krakow
Poland	Research Site	Lodz
Poland	Research Site	Rybnik
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Zamosc
Russian Federation	Research Site	Moscow
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	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	Madrid
Spain	Research Site	Majadahonda	Madrid
Spain	Research Site	Santander	Cantabria
Sweden	Research Site	Karlstad
Sweden	Research Site	Stockholm
Sweden	Research Site	Uppsala
United Kingdom	Research Site	Cambridge
United Kingdom	Research Site	Coventry
United Kingdom	Research Site	London
United Kingdom	Research Site	Nottingham
United Kingdom	Research Site	Sheffield
United States	Research Site	Alexandria	Virginia
United States	Research Site	Alexandria	Virginia
United States	Research Site	Arlington	Texas
United States	Research Site	Arvada	Colorado
United States	Research Site	Augusta	Georgia
United States	Research Site	Austin	Texas
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	Bronx	New York
United States	Research Site	Brookhaven	Mississippi
United States	Research Site	Brooklyn	New York
United States	Research Site	Brooklyn	New York
United States	Research Site	Carrboro	North Carolina
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Chattanooga	Tennessee
United States	Research Site	Chula Vista	California
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Columbia	Tennessee
United States	Research Site	Columbia	South Carolina
United States	Research Site	Columbus	Mississippi
United States	Research Site	Coral Springs	Florida
United States	Research Site	Cudahy	California
United States	Research Site	Denver	Colorado
United States	Research Site	Detroit	Michigan
United States	Research Site	Detroit	Michigan
United States	Research Site	Durham	North Carolina
United States	Research Site	Eatontown	New Jersey
United States	Research Site	Edinburg	Texas
United States	Research Site	Evanston	Illinois
United States	Research Site	Fairfax	Virginia
United States	Research Site	Fairfield	California
United States	Research Site	Fort Worth	Texas
United States	Research Site	Fort Worth	Texas
United States	Research Site	Fort Worth	Texas
United States	Research Site	Glendale	California
United States	Research Site	Grand Prairie	Texas
United States	Research Site	Great Neck	New York
United States	Research Site	Gulfport	Mississippi
United States	Research Site	Gurnee	Illinois
United States	Research Site	Hampton	Virginia
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Kalamazoo	Michigan
United States	Research Site	Kansas City	Missouri
United States	Research Site	Knoxville	Tennessee
United States	Research Site	Lafayette	Louisiana
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Lauderdale Lakes	Florida
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Los Angeles	California
United States	Research Site	Los Angeles	California
United States	Research Site	Los Angeles	California
United States	Research Site	Lubbock	Texas
United States	Research Site	Lynwood	California
United States	Research Site	Macon	Georgia
United States	Research Site	Mansfield	Texas
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	Miami	Florida
United States	Research Site	Michigan City	Indiana
United States	Research Site	Nashville	Tennessee
United States	Research Site	New Bern	North Carolina
United States	Research Site	Norfolk	Virginia
United States	Research Site	Northridge	California
United States	Research Site	Norwalk	California
United States	Research Site	Ocala	Florida
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Ontario	California
United States	Research Site	Orangeburg	South Carolina
United States	Research Site	Orchard Park	New York
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pine Bluff	Arkansas
United States	Research Site	Pinecrest	Florida
United States	Research Site	Pontiac	Michigan
United States	Research Site	Portsmouth	New Hampshire
United States	Research Site	Reno	Nevada
United States	Research Site	Ridgewood	New York
United States	Research Site	Riverside	California
United States	Research Site	Rosedale	New York
United States	Research Site	Saint Louis	Missouri
United States	Research Site	San Antonio	Texas
United States	Research Site	San Antonio	Texas
United States	Research Site	San Antonio	Texas
United States	Research Site	San Gabriel	California
United States	Research Site	Shreveport	Louisiana
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	Tupelo	Mississippi
United States	Research Site	Whittier	California
United States	Research Site	Wichita	Kansas
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,  France,  Germany,  Hungary,  Israel,  Italy,  Netherlands,  Poland,  Russian Federation,  Spain,  Sweden,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs)	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.	From first dose until 30 days after last dose; the treatment period was 52 weeks.
Primary	Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4	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.	52 weeks
Primary	Number of Participants Who Developed Anti-etelcalcetide Antibodies	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.	Baseline, Week 12, Week 24, Week 36, Week 53, the 30-day follow-up visit
Primary	Change From Baseline in Blood Pressure	Blood pressure (BP) values were taken post-hemodialysis assessments.	Baseline and Weeks 24 and 48
Secondary	Percentage of Participants With > 30% Reduction From Baseline in PTH During the Efficacy Assessment Phase	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.	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)
Secondary	Percentage of Participants With > 30% Reduction From Baseline in PTH During the EAP12	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.	Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Secondary	Percentage of Participants With PTH = 300 pg/mL During the EAP		Baseline and the efficacy assessment phase
Secondary	Percentage of Participants With PTH = 300 pg/mL During the EAP12		Week 46 to 53
Secondary	Percent Change From Baseline in Mean PTH During the EAP		Baseline and the efficacy assessment phase
Secondary	Percent Change From Baseline in Mean PTH During the EAP12		Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Secondary	Percent Change From Baseline in Mean Corrected Calcium During the EAP		Baseline and the efficacy assessment phase
Secondary	Percent Change From Baseline in Mean Corrected Calcium During the EAP12		Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Secondary	Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP		Baseline and the efficacy assessment phase
Secondary	Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP12		Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Secondary	Percent Change From Baseline in Mean Phosphorus During the EAP		Baseline and the efficacy assessment phase
Secondary	Percent Change From Baseline in Mean Phosphorus During the EAP12		Baseline and the efficacy assessment phase at month 12 (weeks 46-53)

External Links

•   AmgenTrials clinical trials website