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Linda Shavit, Meyer Lifschitz, Itzchak Slotki
Background and Objectives. Hypoparathyroidism in patients with functioning kidneys leads to hyperphosphatemia. This article reviews data suggesting that hypoparathyroidism in patients on dialysis leads to hypophosphatemia. Design. Clinical data of the following were reviewed: (a) a patient with hypoparathyroidism before and during chronic dialysis; (b) patients on dialysis with surgically created hypoparathyroidism; (c) dialysis patients being treated with Cinacalcet, a calcium-sensing receptor agonist that lowers parathyroid hormone (PTH) levels; and (d) dialysis patients being treated with Velcalcetide, a new calcium-sensing receptor agonist that also lowers PTH...
January 2014: Journal of Investigative Medicine High Impact Case Reports
Kevin J Martin, Gregory Bell, Karen Pickthorn, Saling Huang, Andrew Vick, Peter Hodsman, Munro Peacock
CONTEXT: Velcalcetide, also known as AMG 416, is a novel, long-acting selective peptide agonist of the calcium sensing receptor. It is being developed as an intravenous treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients with chronic kidney disease-mineral and bone disorder. OBJECTIVE: To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of velcalcetide in healthy male volunteers. METHODS: The study was a double-blind, randomized, placebo-controlled, single-dose, dose-escalation study in healthy males aged 18-45 years conducted at a single center...
February 2014: Nephrology, Dialysis, Transplantation
Kevin J Martin, Karen Pickthorn, Saling Huang, Geoffrey A Block, Andrew Vick, Peter F Mount, David A Power, Gregory Bell
AMG 416 (velcalcetide), a novel peptide agonist of the calcium-sensing receptor, lowers plasma parathyroid hormone in preclinical uremic animal models and in normal healthy individuals. Here, we studied its efficacy in hemodialysis patients suffering from secondary hyperparathyroidism. Major inclusion criteria were hemodialysis for at least 3 months, serum parathyroid hormone over 300 pg/ml, a corrected serum calcium of 9.0 mg/dl or more, and stable doses of vitamin D analogs for at least 3 weeks prior to screening...
January 2014: Kidney International
Sarah Walter, Amos Baruch, Jin Dong, James E Tomlinson, Shawn T Alexander, Julie Janes, Tom Hunter, Qun Yin, Derek Maclean, Gregory Bell, Dirk B Mendel, Randolph M Johnson, Felix Karim
A novel peptide, AMG 416 (formerly KAI-4169, and with a United States Adopted Name: velcalcetide), has been identified that acts as an agonist of the calcium-sensing receptor (CaSR). This article summarizes the in vitro and in vivo characterization of AMG 416 activity and the potential clinical utility of this novel compound. AMG 416 activates the human CaSR in vitro, acting by a mechanism distinct from that of cinacalcet, the only approved calcimimetic, since it can activate the CaSR both in the presence or the absence of physiologic levels of extracellular calcium...
August 2013: Journal of Pharmacology and Experimental Therapeutics
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