Clinical trial NCT01932970: Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide
Official title: A Multicenter, Multiple-dose, Single-arm Study to Switch Hemodialysis Subjects With Secondary Hyperparathyroidism From Oral Cinacalcet HCl to Intravenous AMG 416
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperparathyroidism, Secondary
Keywords: Secondary Hyperparathyroidism (SHPT), chronic kidney disease (CKD), hemodialysis, parathyroid hormone (PTH), hypocalcemia, bone and mineral metabolism
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2013-08-30
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL During the 4-week Treatment Period
timeFrame: 4 weeks
Secondary outcomes:
measure: Percent Change From Baseline in Parathyroid Hormone During the Treatment Period
timeFrame: Baseline and weeks 2, 3 and 4
measure: Percentage of Participants With Serum Corrected Calcium < 8.3 mg/dL During the 4-week Treatment Period
timeFrame: 4 weeks
Other outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From the first dose of study drug up to 30 days after the last dose; 8 weeks
measure: Percentage of Participants With Symptomatic Hypocalcemia During the 4-week Treatment Period
timeFrame: From the first dose of study drug up to 30 days after the last dose; 8 weeks
Locations:
city: Alhambra
country: United States
facility: Research Site
state: California
city: Azusa
country: United States
facility: Research Site
state: California
city: Bakersfield
country: United States
facility: Research Site
state: California
city: Chula Vista
country: United States
facility: Research Site
state: California
city: La Mesa
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Lynwood
country: United States
facility: Research Site
state: California
city: Riverside
country: United States
facility: Research Site
state: California
city: Whittier
country: United States
facility: Research Site
state: California
city: Arvada
country: United States
facility: Research Site
state: Colorado
city: North Haven
country: United States
facility: Research Site
state: Connecticut
city: Coral Springs
country: United States
facility: Research Site
state: Florida
city: Hollywood
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Pembroke Pines
country: United States
facility: Research Site
state: Florida
city: Pinecrest
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Augusta
country: United States
facility: Research Site
state: Georgia
city: Evergreen Park
country: United States
facility: Research Site
state: Illinois
city: Michigan City
country: United States
facility: Research Site
state: Indiana
city: Baton Rouge
country: United States
facility: Research Site
state: Louisiana
city: Lafayette
country: United States
facility: Research Site
state: Louisiana
city: Columbus
country: United States
facility: Research Site
state: Mississippi
city: Gulfport
country: United States
facility: Research Site
state: Mississippi
city: Farmington
country: United States
facility: Research Site
state: Missouri
city: Kansas City
country: United States
facility: Research Site
state: Missouri
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Portsmouth
country: United States
facility: Research Site
state: New Hampshire
city: Eatontown
country: United States
facility: Research Site
state: New Jersey
city: College Point
country: United States
facility: Research Site
state: New York
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Orangeburg
country: United States
facility: Research Site
state: South Carolina
city: Arlington
country: United States
facility: Research Site
state: Texas
city: Greenville
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: McAllen
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Fairfax
country: United States
facility: Research Site
state: Virginia
city: Hampton
country: United States
facility: Research Site
state: Virginia
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: