Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder
Secondary Hyperparathyroidism
About this trial
This is an interventional treatment trial for Secondary Hyperparathyroidism focused on measuring Clinical Trial, Phase 2, Renal Dialysis, Secondary Hyperparathyroidism, Chronic kidney disease-mineral and bone disorder, Parathyroid hormone
Eligibility Criteria
Inclusion Criteria:
- 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 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 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
Sites / Locations
Arms of the Study
Arm 1
Experimental
Etelcalcetide
Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.