One-year safety and efficacy of intravenous etelcalcetide in patients on hemodialysis with secondary hyperparathyroidism.
BACKGROUND
Secondary hyperparathyroidism (sHPT), a common complication of chronic kidney disease, is characterized by elevated serum parathyroid hormone (PTH). Etelcalcetide is an intravenous calcimimetic that increases sensitivity of the calcium-sensing receptor to calcium and decreases PTH secretion. This open-label extension (OLE) trial evaluated the long-term effects of etelcalcetide for sHPT treatment in patients receiving hemodialysis.


METHODS
This 52-week, multicenter, single-arm OLE enrolled patients from three parent trials: two randomized, double-blind, placebo-controlled trials and one open-label, single-arm, 'switch' study from cinacalcet to etelcalcetide. The primary endpoint was to investigate the nature, frequency, severity and relation to treatment of all adverse events (AEs) reported throughout the trial. Secondary endpoints included the proportion of patients with >30% reduction from baseline in PTH and the percentage change from baseline in PTH, albumin-corrected calcium (Ca), phosphate (P) and the calcium-phosphate product (Ca × P).ClinicalTrials.gov identifier: NCT01785875; Amgen study: 20120231.


RESULTS
Overall, 89.8% of the patients experienced one or more treatment-emergent AE. The most common were decreased blood Ca (43.3%), diarrhea (10.8%), vomiting (10.4%) and nausea (9.6%); symptomatic hypocalcemia occurred in 3.7% of the patients. Approximately 68% of patients achieved >30% reduction in PTH, and ∼56% achieved PTH ≤300 pg/mL. Mean percent changes from baseline ranged from -25.4% to -26.1% for PTH, -8.3% to -9.1% for Ca, -3.6% to -4.1% for P and -12.0% to -12.6% for Ca × P.


CONCLUSIONS
Etelcalcetide effectively lowered PTH and its effect was sustained, while no new safety concerns emerged over a 1-year treatment period.
['Bushinsky|David A|DA|', 'Chertow|Glenn M|GM|', 'Cheng|Sunfa|S|', 'Deng|Hongjie|H|', 'Kopyt|Nelson|N|', 'Martin|Kevin J|KJ|', 'Rastogi|Anjay|A|', 'Ureña-Torres|Pablo|P|', 'Vervloet|Marc|M|', 'Block|Geoffrey A|GA|']
D061605:Administration, Intravenous D000368:Aged D002118:Calcium D004311:Double-Blind Method D005260:Female D006801:Humans D006962:Hyperparathyroidism, Secondary D008297:Male D010281:Parathyroid Hormone D010455:Peptides D011379:Prognosis D006435:Renal Dialysis D051436:Renal Insufficiency, Chronic
etelcalcetide chronic kidney disease open-label extension safety, secondary hyperparathyroidism