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

Completed · Phase 3

Conditions studied: Hyperparathyroidism, Secondary

In brief

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.

Key facts

Study ID

NCT02102204

Run by

Amgen

People needed

902

Starts

2014-03-25

Expected to finish

2017-06-26

Last updated by the study team

2017-11-17

Who can join

Age: 18 and older, up to 110. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Alhambra, California, United States
• Research Site — Azusa, California, United States
• Research Site — Bakersfield, California, United States
• Research Site — Cudahy, California, United States
• Research Site — Granada Hills, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Northridge, California, United States
• Research Site — Riverside, California, United States
• Research Site — Simi Valley, California, United States
• Research Site — Vacaville, California, United States
• Research Site — Whittier, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — Westminster, Colorado, United States
• Research Site — Stamford, Connecticut, United States
• Research Site — Miami, Florida, United States
• Research Site — Ocala, Florida, United States
• Research Site — Pembroke Pines, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Augusta, Georgia, United States
• Research Site — Dublin, Georgia, United States
• Research Site — Meridian, Idaho, United States
• Research Site — Highland Park, Illinois, United States
• Research Site — Merrillville, Indiana, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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