Parsabiv
Evidence Grade A — Regulatory approved. 138 published studies. 23 registered clinical trials.
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Etelcalcetide (sold as Parsabiv) is a medication given intravenously during dialysis to treat overactive parathyroid glands in people with chronic kidney disease. When the kidneys fail, calcium and phosphorus regulation goes awry, causing the parathyroid glands to produce too much hormone — which can lead to bone disease and dangerous calcium build-up in blood vessels. Parsabiv helps bring parathyroid hormone levels back under control.
138 published studies: 94 human, 5 animal, 12 in-vitro, 33 reviews
Etelcalcetide is marketed as Parsabiv (approved February 2017) for secondary hyperparathyroidism in adults with chronic kidney disease on haemodialysis. It is administered intravenously three times per week at the end of dialysis sessions.
In a head-to-head trial against cinacalcet (an oral calcimimetic), etelcalcetide was superior — 68.2% of patients achieved a meaningful PTH reduction compared to 57.7% with cinacalcet. The key practical advantage is that it is given by dialysis staff during treatment sessions, eliminating the need for patients to remember daily oral medication. However, it cannot be used by kidney disease patients who are not yet on dialysis, where the oral alternative cinacalcet remains the option.
In chronic kidney disease, the body's calcium regulation goes awry, and the parathyroid glands produce too much parathyroid hormone (PTH), leading to bone disease and vascular calcification. Etelcalcetide works by enhancing the calcium-sensing receptor on parathyroid cells, essentially making these cells more sensitive to calcium in the blood. This tricks the glands into thinking calcium levels are adequate, causing them to reduce PTH production. It physically attaches to the receptor via a chemical bond, providing a sustained effect.
In a head-to-head trial against the oral alternative cinacalcet, etelcalcetide was statistically superior — 68% of patients achieved a meaningful reduction in parathyroid hormone compared to 58% with cinacalcet. The key practical advantage is compliance: because dialysis staff administer it during treatment sessions, patients do not need to remember a daily pill. For a population already managing complex medication regimens, this guaranteed adherence is valuable. The main limitations are that it can only be used by patients on haemodialysis (not earlier-stage kidney disease) and it carries a risk of low calcium levels (hypocalcaemia) that requires monitoring. Research is ongoing into potential cardiovascular benefits and effects on vascular calcification in dialysis patients.
MT1013 Injection for the Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease
Use of ETElcalcetidefor pReserving vitamiN K-dependent proteIn activiTY ITAlian Study
A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis
A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients
A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
EMA Marketing Authorisation
FDA ORIG 1
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