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

Amgen

Status and phase: Completed; Phase 3

Conditions: Hyperparathyroidism, Secondary

Treatments: Drug: Etelcalcetide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02102204

KAI-4169 (Other Identifier)

2013-004136-30 (EudraCT Number)

20130213

Details and patient eligibility

About

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.

Full description

This is a multicenter, single-arm, extension study in which adults with secondary hyperparathyroidism currently receiving hemodialysis and previously treated in Amgen studies 20120231 (NCT01785875), 20120334 (NCT01576146), or 20120360 (NCT01896232) will continue to be treated with etelcalcetide until approximately 2.5 years after the first participant was enrolled.

Enrollment: 902 patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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902 participants in 1 patient group

Etelcalcetide

Experimental group

Description:

Participants received etelcalcetide three times a week (TIW) by bolus injection at the end of hemodialysis. The minimum etelcalcetide dose in this study was 2.5 mg and the maximum dose was 15 mg. Etelcalcetide dose was titrated to maintain parathyroid hormone levels within 2x to 9x the upper limit of normal based on the reference range of the assay used at the individual study center.

Treatment:

Drug: Etelcalcetide