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

KAI Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Hyperparathyroidism, Secondary

Treatments

Drug: Etelcalcetide

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01134562

KAI-4169-002

20130139 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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