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

Completed · Phase 2 · Has a placebo group

Conditions studied: Secondary Hyperparathyroidism

In brief

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).

Key facts

Study ID

NCT01254565

Run by

KAI Pharmaceuticals

People needed

87

Starts

2011-02-20

Expected to finish

2011-08-24

Last updated by the study team

2017-04-13

Who can join

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

You may qualify if…

• 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.

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

Where it is running

• Study site — Azusa, California, United States
• Study site — Costa Mesa, California, United States
• Study site — Lynwood, California, United States
• Study site — Riverside, California, United States
• Study site — San Diego, California, United States
• Study site — Denver, Colorado, United States
• Study site — Macon, Georgia, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Brooklyn Center, Minnesota, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Houston, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Chesapeake, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.