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

• Status: Completed
• Trial end date: 2011-04-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: KAI Pharmaceuticals

Criteria

Inclusion Criteria:

• Subjects provides written informed consent.

• Intact parathyroid hormone (iPTH) ≥ 400 pg/mL (≥ 300 and < 1200 pg/ml for Cohorts 1-3).

• Serum corrected calcium ≥ 9.0 mg/dL

• Receiving hemodialysis three times per week for at least 3 months and had adequate hemodialysis with a delivered Kt/V (dialyzer clearance of urea * dialysis time/ volume of distribution of urea) ≥ 1.2 or urea reduction ratio (URR)

≥ 65%.

• 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