Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide

Hyperparathyroidism, Secondary Clinical Trial

Official title:

A Multicenter, Multiple-dose, Single-arm Study to Switch Hemodialysis Subjects With Secondary Hyperparathyroidism From Oral Cinacalcet HCl to Intravenous AMG 416

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932970
• Other study ID #: 20120359
• Secondary ID: 2013-000964-28KA
• Status: Completed
• Phase: Phase 3
• Start date: August 12, 2013
• Est. completion date: February 14, 2017

Study information

• Verified date: September 2018
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on serum corrected calcium levels when switching patients from cinacalcet to etelcalcetide (AMG 416).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: February 14, 2017
• Est. primary completion date: January 14, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria

• Subject is 18 years of age or older at the time of informed consent.

• Subject must be receiving maintenance hemodialysis 3 times weekly for at least 8 weeks.

• Subject must have SHPT as defined by having a mean of 3 consecutive central laboratory screening predialysis serum parathyroid hormone (PTH) values = 200 pg/mL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet.

• Subject must have a mean of 3 consecutive central laboratory screening predialysis serum corrected calcium (cCa) values = 7.5 mg/dL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet.

• Subject must be on a stable dose of cinacalcet before screening (defined as no dose change within the 4 weeks prior to screening).

• Other Inclusion Criteria may apply.

Exclusion Criteria

• Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s).

• Subject has received AMG 416 in a prior clinical trial of AMG 416 (also known as KAI-4169).

• Subject has known sensitivity to any of the products or components of AMG 416 to be administered during dosing.

• Subject is unwilling to use effective contraception during the study, and for women, up to a period of up to 3 months after the last dose of AMG 416.

• Subject is pregnant or nursing.

• Anticipated or scheduled parathyroidectomy during the study period.

• Subject has received a parathyroidectomy within 6 months prior to dosing.

• Other Exclusion Criteria may apply.

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Neoplasm Metastasis

Intervention

Drug:
• Etelcalcetide
Etelcalcetide is provided as a sterile lyophilized powder to be reconstituted with sterile water for injection.

Locations

Country	Name	City	State
United States	Research Site	Alhambra	California
United States	Research Site	Arlington	Texas
United States	Research Site	Arvada	Colorado
United States	Research Site	Augusta	Georgia
United States	Research Site	Azusa	California
United States	Research Site	Bakersfield	California
United States	Research Site	Baton Rouge	Louisiana
United States	Research Site	Chula Vista	California
United States	Research Site	College Point	New York
United States	Research Site	Columbus	Mississippi
United States	Research Site	Coral Springs	Florida
United States	Research Site	Eatontown	New Jersey
United States	Research Site	Evergreen Park	Illinois
United States	Research Site	Fairfax	Virginia
United States	Research Site	Farmington	Missouri
United States	Research Site	Greenville	Texas
United States	Research Site	Gulfport	Mississippi
United States	Research Site	Hampton	Virginia
United States	Research Site	Hollywood	Florida
United States	Research Site	Houston	Texas
United States	Research Site	Kansas City	Missouri
United States	Research Site	La Mesa	California
United States	Research Site	Lafayette	Louisiana
United States	Research Site	Los Angeles	California
United States	Research Site	Lynwood	California
United States	Research Site	McAllen	Texas
United States	Research Site	Miami	Florida
United States	Research Site	Michigan City	Indiana
United States	Research Site	North Haven	Connecticut
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orangeburg	South Carolina
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pinecrest	Florida
United States	Research Site	Portsmouth	New Hampshire
United States	Research Site	Riverside	California
United States	Research Site	Saint Louis	Missouri
United States	Research Site	San Antonio	Texas
United States	Research Site	Tampa	Florida
United States	Research Site	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Adverse Events		From the first dose of study drug up to 30 days after the last dose; 8 weeks
Other	Percentage of Participants With Symptomatic Hypocalcemia During the 4-week Treatment Period	Hpocalcemia was used for events of decreased calcium accompanied by clinical signs and symptoms of hypocalcemia.	From the first dose of study drug up to 30 days after the last dose; 8 weeks
Primary	Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL During the 4-week Treatment Period		4 weeks
Secondary	Percent Change From Baseline in Parathyroid Hormone During the Treatment Period		Baseline and weeks 2, 3 and 4
Secondary	Percentage of Participants With Serum Corrected Calcium < 8.3 mg/dL During the 4-week Treatment Period		4 weeks

External Links

•   AmgenTrials clinical trials website