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



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Endocrine
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:18 - 85
Updated:10/19/2018
Start Date:August 13, 2013
End Date:January 8, 2015

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A Multicenter, Multiple-dose, Two-arm, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet HCl With Intravenous Doses of AMG 416 in Hemodialysis Subjects With Secondary Hyperparathyroidism

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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- Eligible subjects cannot have received cinacalcet during the 3 months preceding the
first screening laboratory assessment

- Other criteria may apply
We found this trial at
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Wilmington, North Carolina 28401
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