Conditions: Secondary Hyperparathyroidism
Keywords: Clinical Trial, Phase 2 Renal Dialysis Secondary Hyperparathyroidism Parathyroid hormone
Allocation: RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 87
Healthy volunteers: no

Brief summary:
The purpose of this study is to characterize the safety and tolerability and efficacy of multiple ascending doses of etelcalcetide in hemodialysis patients for the treatment of secondary hyperparathyroidism (HPT).

Detailed description:

Arms:
arm 1: Participants received etelcalcetide administered by intravenous injection at the end of each hemodialysis session three times a week (TIW). The starting dose level was 5 mg; dose escalation was to proceed to 10 and 20 mg pending safety review of the prior cohort. arm 2: Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW).

Interventions: intervention 1: Etelcalcetide intervention 2: Placebo
Intervention descriptions: intervention 1: Administered intravenously (IV) at the end of hemodialysis intervention 2: Administered intravenously at the end of hemodialysis

Protocol document: