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

Amgen

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease; Secondary Hyperparathyroidism

Treatments: Drug: Oral Placebo; Drug: Etelcalcetide; Drug: Cinacalcet; Drug: Intravenous Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01896232

2013-000192-33 (EudraCT Number)

20120360

Details and patient eligibility

About

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.

Enrollment: 683 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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683 participants in 2 patient groups

Cinacalcet

Active Comparator group

Description:

Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.

Treatment:

Drug: Intravenous Placebo

Drug: Cinacalcet

Etelcalcetide

Experimental group

Description:

Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.

Treatment:

Drug: Oral Placebo

Drug: Etelcalcetide