Intravenous calcimimetic for secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis.
Regulatory status
Approved (FDA / EMA)
Family
Peptide calcimimetic
Scientific evidence
High
Number of findings
2
Where it acts
Heart and blood · Hormones and metabolism · Bones and muscles
Also known as
etelcalcetide, Parsabiv, AMG 416, velcalcetide
Regulatory status
FDA (US): Approved (2017, Parsabiv) for secondary hyperparathyroidism in adults with CKD on hemodialysis.
EMA (EU): Approved (2016, Parsabiv) for secondary hyperparathyroidism in adults with CKD on hemodialysis.
Dose
Start with 5 mg three times a week intravenously at the end of dialysis, adjusting according to PTH and calcium (EMA/FDA Parsabiv label).
Safety
Drop in blood calcium (sometimes with cramps or ECG changes), muscle spasms, nausea, vomiting, diarrhea. May worsen heart failure and prolong the QT interval through hypocalcemia. Only in dialysis units.
Interactions
Do not combine with cinacalcet (risk of severe hypocalcemia). Caution with other drugs that lower calcium.
Effect by goal · level of evidence
PTH reduction versus placebo
reducesHighRCT (AA)in people
75% vs 9% response
Two RCTs with 1,023 hemodialysis patients: PTH fell by more than 30% in 74–75% with etelcalcetide versus 8–10% with placebo. More nausea, vomiting, and muscle spasms.
It binds to and activates the calcium sensor of the parathyroid glands, as if there were more calcium. The glands produce less PTH. PTH, calcium, and phosphorus go down, which in dialysis damage bone and blood vessels.
What the evidence says
In people
PTH reduction versus placebo. Two RCTs with 1,023 hemodialysis patients: PTH fell by more than 30% in 74–75% with etelcalcetide versus 8–10% with placebo. More nausea, vomiting, and muscle spasms. PubMed 28097355
More effective than cinacalcet. RCT with 683 patients: PTH reduction >30% in 68.2% with etelcalcetide versus 57.7% with oral cinacalcet; >50% in 52.4% versus 40.2%. PubMed 28097356