Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder

A Single-arm, Open-label, Multicenter, Dose Titration Study of KAI-4169 to Treat Secondary Hyperparathyroidism in Hemodialysis Subjects With Chronic Kidney Disease-Mineral and Bone Disorder

The purpose of this study is to evaluate the effect of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients with chronic kidney disease-mineral and bone disorder (CKD-MBD).

Inclusion Criteria:

• Subjects provides written informed consent
• Screening intact PTH (iPTH) ≥ 350 pg/mL and corrected calcium ≥ 8.5 mg/dL
• Hemoglobin ≥ 8.5 g/dL
• Serum transaminases (alanine transaminase [ALT], aspartate transaminase [AST]) less than 2.5 times the upper limit of normal
• Adequate hemodialysis three times per week

Exclusion Criteria:

• History or symptomatic ventricular dysrhythmias
• History of angina pectoris or congestive heart failure
• History of myocardial infarction, coronary angioplasty, or coronary artery bypass grafting within the past 6 months
• History of or treatment for seizure disorder within the last 12 months
• Postdialysis systolic blood pressure > 180 mmHg or diastolic blood pressure > 90 mmHg
• Serum magnesium below the lower limit of normal at screening