Status:
COMPLETED
Safety, Tolerability and Efficacy of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
Lead Sponsor:
KAI Pharmaceuticals
Conditions:
Secondary Hyperparathyroidism
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 hyperparathyr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 20 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2011
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT01254565
Start Date
February 20 2011
End Date
August 24 2011
Last Update
April 13 2017
Active Locations (13)
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1
Azusa, California, United States, 91702
2
Costa Mesa, California, United States, 92626
3
Lynwood, California, United States, 90262
4
Riverside, California, United States, 92505