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  • Velcalcetide (AMG 416), a novel peptide agonist of the calcium-sensing receptor, reduces serum parathyroid hormone and FGF23 levels in healthy male subjects #MMPMID24235081
  • Martin KJ; Bell G; Pickthorn K; Huang S; Vick A; Hodsman P; Peacock M
  • Nephrol Dial Transplant 2014[Feb]; 29 (2): 385-92 PMID24235081show ga
  • 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. Each cohort included eight subjects randomized 6:2 to velcalcetide or placebo. INTERVENTION: Velcalcetide at 0.5, 2, 5 and 10 mg or placebo was administered intravenously. OUTCOMES: Measurements included plasma ionized calcium (iCa), serum total calcium, intact parathyroid hormone (iPTH), phosphorus and fibroblast growth factor-23 (FGF23), 1,25-dihydroxyvitamin D, calcitonin and urine creatinine, calcium and phosphorus and plasma pharmacokinetics for velcalcetide. Vital signs, safety biochemical and hematological indices, and adverse events were monitored throughout the study. RESULTS: Intravenous administration of velcalcetide was well tolerated with no adverse reaction of nausea, vomiting or diarrhea reported. Velcalcetide mediated dose-dependent decreases in serum iPTH at 30 min, FGF23 at 24 h and iCa at 12 h post dose (P<0.05) and in urine fractional excretion of phosphorus and increases in tubular reabsorption of phosphorus. Velcalcetide plasma exposure increased in a dose-related manner and the terminal elimination of half-life was comparable across the dose range evaluated and ranged from 18.4 to 20.0 h. CONCLUSION: Single IV doses of velcalcetide were well tolerated and associated with rapid, sustained, dose-dependent reductions in serum PTH. The results support further evaluation of velcalcetide as a treatment for SHPT in hemodialysis patients.
  • |Adolescent[MESH]
  • |Adult[MESH]
  • |Biomarkers/blood[MESH]
  • |Chronic Kidney Disease-Mineral and Bone Disorder/blood/complications/*drug therapy[MESH]
  • |Dose-Response Relationship, Drug[MESH]
  • |Double-Blind Method[MESH]
  • |Fibroblast Growth Factor-23[MESH]
  • |Fibroblast Growth Factors/*blood/drug effects[MESH]
  • |Follow-Up Studies[MESH]
  • |Humans[MESH]
  • |Hyperparathyroidism, Secondary/blood/*drug therapy/etiology[MESH]
  • |Injections, Intravenous[MESH]
  • |Male[MESH]
  • |Middle Aged[MESH]
  • |Parathyroid Hormone/*blood[MESH]
  • |Peptides/pharmacokinetics/*pharmacology[MESH]
  • |Receptors, Calcium-Sensing/*agonists[MESH]
  • |Reference Values[MESH]
  • |Renal Insufficiency, Chronic/blood/*complications/drug therapy[MESH]
  • |Time Factors[MESH]
  • |Treatment Outcome[MESH]
  • |Young Adult[MESH]

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  • suck abstract from ncbi

    385 2.29 2014