Trial reportNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2014
Velcalcetide (AMG 416), a novel peptide agonist of the calcium-sensing receptor, reduces serum parathyroid hormone and FGF23 levels in healthy male subjects.
Trial report in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
26 citing papers in PubMed.
- The pharmacokinetics, pharmacodynamics and tolerability of SHR6508 in chinese healthy subjects: a randomized, placebo-controlled, double-blind, single-dose and dose-escalation phase I trial.Naunyn-Schmiedeberg's archives of pharmacology · 2025Trial
- Review
- Calcium and Neural Stem Cell Proliferation.International journal of molecular sciences · 2024Review
- Secondary Hyperparathyroidism in Chronic Kidney Disease: Pathophysiology and Management.Cureus · 2021Review
- Phosphate Metabolism in Health and Disease.Calcified tissue international · 2021Review
- Recent advances in understanding and managing secondary hyperparathyroidism in chronic kidney disease.F1000Research · 2020Review
- Effect of etelcalcetide on cardiac hypertrophy in hemodialysis patients: a randomized controlled trial (ETECAR-HD).Trials · 2019Article
- Novel Bivalent and D-Peptide Ligands of CXCR4 Mobilize Hematopoietic Progenitor Cells to the Blood in C3H/HeJ Mice.Cell transplantation · 2018Article
- Strong G-Protein-Mediated Inhibition of Sodium Channels.Cell reports · 2018Article
- 2017 FDA Peptide Harvest.Pharmaceuticals (Basel, Switzerland) · 2018Review
- Managing hyperparathyroidism in hemodialysis: role of etelcalcetide.International journal of nephrology and renovascular disease · 2018Review
- Etelcalcetide, A Novel Calcimimetic, Prevents Vascular Calcification in A Rat Model of Renal Insufficiency with Secondary Hyperparathyroidism.Calcified tissue international · 2017Article
- Formulary Drug Review: Etelcalcetide.Hospital pharmacy · 2017Review
- Secondary Hyperparthyroidism: Pathogenesis, Diagnosis, Preventive and Therapeutic Strategies.Reviews in endocrine & metabolic disorders · 2017Review
- Drug disposition model of radiolabeled etelcalcetide in patients with chronic kidney disease and secondary hyperparathyroidism on hemodialysis.Journal of pharmacokinetics and pharmacodynamics · 2017Article
- Pharmacokinetics, Biotransformation, and Excretion of [Clinical pharmacokinetics · 2017Article
- Diseases associated with calcium-sensing receptor.Orphanet journal of rare diseases · 2017Review
- Treatment of secondary hyperparathyroidism: the clinical utility of etelcalcetide.Therapeutics and clinical risk management · 2017Review
- Review
- Etelcalcetide: First Global Approval.Drugs · 2016Review
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
contextVelcalcetide, 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.
objectiveTo assess the safety, tolerability, pharmacokinetics and pharmacodynamics of velcalcetide in healthy male volunteers.
methodsThe 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.
interventionVelcalcetide 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.
resultsIntravenous 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.
conclusionSingle 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.
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