Conditions: Hyperparathyroidism, Secondary
Keywords: Secondary Hyperparathyroidism (SHPT), chronic kidney disease (CKD), hemodialysis, parathyroid hormone (PTH), hypocalcemia, bone and mineral metabolism
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 158
Healthy volunteers: no

Brief summary:
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).

Detailed description:

Arms:
arm 1: 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.

Interventions: intervention 1: Etelcalcetide
Intervention descriptions: intervention 1: Etelcalcetide is provided as a sterile lyophilized powder to be reconstituted with sterile water for injection.

Protocol document: