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

• Status: Completed
• Trial end date: 2017-06-26
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen

Criteria

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