Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet

Completed · Phase 3 · Has a placebo group

Conditions studied: Secondary Hyperparathyroidism, Chronic Kidney Disease

In brief

The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by \> 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.

Key facts

Study ID

NCT01896232

Run by

Amgen

People needed

683

Starts

2013-08-13

Expected to finish

2015-01-08

Last updated by the study team

2019-07-18

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eligible subjects must be receiving adequate thrice weekly maintenance hemodialysis with a dialysate calcium concentration ≥ 2.5 mEq/L for at least 3 months prior to screening laboratory assessments
• Subjects must have SHPT as defined by one central laboratory screening predialysis serum PTH value > 500 pg/mL, measured on separate days within 2 weeks prior to randomization
• Subjects must have one serum cCa value ≥ 8.3 mg/dL obtained before dialysis within 2 weeks of the date of randomization
• Subjects receiving calcium supplements must have no more than a maximum dose change of 50% within 2 weeks before screening laboratory assessments are obtained, and the dose must remain unchanged through randomization

You may not qualify if…

• Eligible subjects cannot have received cinacalcet during the 3 months preceding the first screening laboratory assessment
• Other criteria may apply

Where it is running

• Research Site — Bakersfield, California, United States
• Research Site — Bakersfield, California, United States
• Research Site — Chula Vista, California, United States
• Research Site — Covina, California, United States
• Research Site — Granada Hills, California, United States
• Research Site — La Mesa, California, United States
• Research Site — La Puente, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Gabriel, California, United States
• Research Site — Whittier, California, United States
• Research Site — Arvada, Colorado, United States
• Research Site — Aurora, Colorado, United States
• Research Site — Longmont, Colorado, United States
• Research Site — Westminster, Colorado, United States
• Research Site — Orange, Connecticut, United States
• Research Site — Pembroke Pines, Florida, United States
• Research Site — Pinecrest, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Baton Rouge, Louisiana, United States
• Research Site — Lafayette, Louisiana, United States
• Research Site — Southgate, Michigan, United States
• Research Site — Columbus, Mississippi, United States
• Research Site — Gulfport, Mississippi, United States
• Research Site — Azusa, California, United States

Full record on ClinicalTrials.gov

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