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

Amgen

Status and phase: Completed; Phase 3

Conditions: Hyperparathyroidism, Secondary

Treatments: Drug: Etelcalcetide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01932970

KAI-4169 (Other Identifier)

2013-000964-28 (EudraCT Number)

20120359

Details and patient eligibility

About

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).

Enrollment: 158 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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158 participants in 1 patient group

Etelcalcetide

Experimental group

Description:

Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.

Treatment:

Drug: Etelcalcetide