Status:
COMPLETED
Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder
Lead Sponsor:
KAI Pharmaceuticals
Conditions:
Secondary Hyperparathyroidism
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effect of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients ...
Eligibility Criteria
Inclusion
- Subjects provides written informed consent
- Screening intact PTH (iPTH) ≥ 350 pg/mL and corrected calcium ≥ 8.5 mg/dL
- Hemoglobin ≥ 8.5 g/dL
- Serum transaminases (alanine transaminase \[ALT\], aspartate transaminase \[AST\]) less than 2.5 times the upper limit of normal
- Adequate hemodialysis three times per week
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 within the last 12 months
- Postdialysis systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 90 mmHg
- Serum magnesium below the lower limit of normal at screening
Key Trial Info
Start Date :
December 5 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2012
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01414114
Start Date
December 5 2011
End Date
May 21 2012
Last Update
April 11 2017
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