Conditions: Hyperparathyroidism, Secondary
Keywords: Clinical Trial, Phase 1 Renal Dialysis Secondary Hyperparathyroidism Parathyroid hormone
Allocation: RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 28
Healthy volunteers: no

Brief summary:
The purpose of this study is to characterize the safety and tolerability of single rising doses of etelcalcetide in hemodialysis patients with secondary hyperparathyroidism.

Detailed description:

Arms:
arm 1: Participants received a single dose of placebo intravenous (IV) injection after hemodialysis. arm 2: Participants received a single dose of etelcalcetide by intravenous (IV) injection after hemodialysis.

Interventions: intervention 1: Placebo intervention 2: Etelcalcetide
Intervention descriptions: intervention 1: Single IV injection. intervention 2: Single IV injection. The initial dose was 5 mg and dose escalation proceeded with subsequent doses of 10 mg, 20 mg, 40 mg and 60 mg.

Protocol document: