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Kidney Int. 2014 Jan;85(1):191-7. doi: 10.1038/ki.2013.289. Epub 2013 Jul 31.

AMG 416 (velcalcetide) is a novel peptide for the treatment of secondary hyperparathyroidism in a single-dose study in hemodialysis patients.

Author information

1
Division of Nephrology, Saint Louis University School of Medicine, Saint Louis, Missouri, USA.
2
Amgen, Inc, Thousand Oaks, California, USA.
3
Denver Nephrology, Denver, Colorado, USA.
4
WIL Research, Ashland, Ohio, USA.
5
Austin Hospital, Melbourne, Victoria, Australia.
6
1] Amgen, Inc, Thousand Oaks, California, USA [2] University of California, San Francisco, California, USA.

Abstract

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. 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.

PMID:
23903371
DOI:
10.1038/ki.2013.289
[Indexed for MEDLINE]
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