Safety, Tolerability and Efficacy of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism

A Double-Blind, Randomized, Placebo-Controlled Multiple Ascending Dose Study to Assess the Safety, Tolerability and Efficacy of KAI-4169 in Hemodialysis Subjects With Secondary Hyperparathyroidism

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).

Inclusion Criteria:

• Subject provides written informed consent.
• Intact parathyroid hormone (PTH) at least 350 pg/mL.
• Corrected calcium at least 9.0 mg/dL.
• Hemoglobin at least 9.0 g/dL.
• Adequate hemodialysis three times per week.
• Excepting chronic renal failure, subject is judged to be in stable medical condition based on medical history, physical examination, and routine laboratory tests.

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.
• Recent (3 months) parathyroidectomy.
• Serum transaminases (alanine aminotransferase, aspartate aminotransferase) greater than two times the upper limit of normal at screening.