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

Completed · Phase 3

Conditions studied: Hyperparathyroidism, Secondary

In brief

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).

Key facts

Study ID: NCT01932970
Run by: Amgen
People needed: 158
Starts: 2013-08-12
Expected to finish: 2017-02-14
Last updated by the study team: 2018-10-17

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Research Site — Alhambra, California, United States
Research Site — Azusa, California, United States
Research Site — Bakersfield, California, United States
Research Site — Chula Vista, California, United States
Research Site — La Mesa, California, United States
Research Site — Los Angeles, California, United States
Research Site — Lynwood, California, United States
Research Site — Riverside, California, United States
Research Site — Whittier, California, United States
Research Site — Arvada, Colorado, United States
Research Site — North Haven, Connecticut, United States
Research Site — Coral Springs, Florida, United States
Research Site — Hollywood, Florida, United States
Research Site — Miami, Florida, United States
Research Site — Pembroke Pines, Florida, United States
Research Site — Pinecrest, Florida, United States
Research Site — Tampa, Florida, United States
Research Site — Augusta, Georgia, United States
Research Site — Evergreen Park, Illinois, United States
Research Site — Michigan City, Indiana, United States
Research Site — Baton Rouge, Louisiana, United States
Research Site — Lafayette, Louisiana, United States
Research Site — Columbus, Mississippi, United States
Research Site — Gulfport, Mississippi, United States
Research Site — Farmington, Missouri, United States

Full record on ClinicalTrials.gov

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