Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/11826
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dc.contributor.authorMartin, Kevin J-
dc.contributor.authorPickthorn, Karen-
dc.contributor.authorHuang, Saling-
dc.contributor.authorBlock, Geoffrey A-
dc.contributor.authorVick, Andrew-
dc.contributor.authorMount, Peter F-
dc.contributor.authorPower, David Anthony-
dc.contributor.authorBell, Gregory-
dc.date.accessioned2015-05-16T01:27:18Z
dc.date.available2015-05-16T01:27:18Z
dc.date.issued2013-07-31-
dc.identifier.citationKidney International 2013en_US
dc.identifier.otherPUBMEDen
dc.identifier.urihttps://ahro.austin.org.au/austinjspui/handle/1/11826en
dc.description.abstractAMG 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. Twenty-eight patients were enrolled in one of five cohorts (5, 10, 20, 40, 60 mg). Cohorts 1-3 (four patients each) were treated in a two-period crossover design, while cohorts 4 and 5 (eight patients each) were randomized 1:1 to AMG 416 or placebo. Patients were admitted to a clinical research unit following hemodialysis and studied for 3 days prior to discharge for hemodialysis. Single intravenous doses of AMG 416 from 5 to 60 mg were well tolerated, and plasma levels increased in a dose-related manner. AMG 416 treatment was associated with significant, dose-dependent reductions in serum parathyroid hormone and fibroblast growth factor 23. Compared with placebo, all dose groups of 10 mg or more were associated with attenuation in the rise in serum phosphate during the interdialytic period. Dose-dependent reductions in serum calcium were observed and were well tolerated. Thus, AMG 416 represents a novel therapeutic approach for the treatment of secondary hyperparathyroidism in hemodialysis patients.en_US
dc.language.isoenen
dc.subject.otherAdulten
dc.subject.otherAgeden
dc.subject.otherAged, 80 and overen
dc.subject.otherFemaleen
dc.subject.otherHumansen
dc.subject.otherHyperparathyroidism, Secondary.drug therapyen
dc.subject.otherInjections, Intravenousen
dc.subject.otherKidney Failure, Chronic.complications.therapyen
dc.subject.otherMaleen
dc.subject.otherMiddle Ageden
dc.subject.otherPeptides.administration & dosage.therapeutic useen
dc.subject.otherRenal Dialysisen
dc.titleAMG 416 (velcalcetide) is a novel peptide for the treatment of secondary hyperparathyroidism in a single-dose study in hemodialysis patients.en_US
dc.typeJournal Articleen_US
dc.identifier.journaltitleKidney Internationalen_US
dc.identifier.affiliationAmgen, Inc, ThoUSAnd Oaks, California, USAen_US
dc.identifier.affiliationAustin Healthen_US
dc.identifier.affiliationWIL Research, Ashland, Ohio, USAen_US
dc.identifier.affiliationDenver Nephrology, Denver, Colorado, USAen_US
dc.identifier.affiliationDivision of Nephrology, Saint Louis University School of Medicine, Saint Louis, Missouri, USAen_US
dc.identifier.affiliationUniversity of California, San Francisco, California, USAen_US
dc.identifier.affiliationAmgen, Inc, ThoUSAnd Oaks, California, USAen_US
dc.identifier.doi10.1038/ki.2013.289en_US
dc.description.pages191-7en
dc.relation.urlhttps://pubmed.ncbi.nlm.nih.gov/23903371en
dc.type.contentTexten_US
dc.type.austinJournal Articleen
local.name.researcherMount, Peter F
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.cerifentitytypePublications-
item.fulltextNo Fulltext-
item.grantfulltextnone-
item.languageiso639-1en-
item.openairetypeJournal Article-
crisitem.author.deptNephrology-
crisitem.author.deptInstitute for Breathing and Sleep-
crisitem.author.deptMedicine (University of Melbourne)-
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