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

Completed · Phase 1 · Has a placebo group

Conditions studied: Hyperparathyroidism, Secondary

In brief

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

Key facts

Study ID

NCT01134562

Run by

KAI Pharmaceuticals

People needed

28

Starts

2010-09-07

Expected to finish

2011-04-02

Last updated by the study team

2018-01-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Cypress, California, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Houston, Texas, United States
• Study site — Brisbane, Queensland, Australia
• Study site — Melbourne, Victoria, Australia

Full record on ClinicalTrials.gov

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