A 12-week dose-escalating study of etelcalcetide (ONO-5163/AMG 416), a novel intravenous calcimimetic, for secondary hyperparathyroidism in Japanese hemodialysis patients
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Abstract

AIMS:

To evaluate dose-escalation of etelcalcetide (ONO-5163/AMG 416), a novel, intravenous (IV), long-acting calcium-sensing receptor agonist, for treatment of secondary hyperparathyroidism (SHPT) in Japanese hemodialysis patients.

MATERIALS AND METHODS:

In this multicenter study, IV injections of etelcalcetide (3 times a week for 12 weeks) were administered, with dose escalation every 4 weeks depending on changes in serum intact parathyroid hormone (iPTH) and corrected calcium (cCa). A total of 24 patients participated in this study.

RESULTS:

Serum iPTH was reduced in a time- and dose-dependent manner, with reductions (in pg/mL) at 12 weeks of -226.1 ± 125.3, -362.5 ± 161.5, and -412.4 ± 130.2, respectively, for maximum doses of 5, 10, and 15 mg. At the end of the treatment, 50% of patients had serum iPTH levels within the target range (60 - 240 pg/mL). Serum cCa and phosphorus were reduced in parallel with iPTH. Adverse events (AEs) occurred in 20 patients (83.3%). The most frequently observed AEs (> 10%) were either mild or moderate nasopharyngitis (29.2%), decreased serum calcium (16.7%), and vomiting (12.5%).

CONCLUSIONS:

Dose-escalated triweekly etelcalcetide was effective for SHPT in Japanese hemodialysis patients and was satisfactorily tolerated.
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• Authors: Keitaro Yokoyama, Masafumi Fukagawa, Takashi Shigematsu, Takashi Akiba, Akifumi Fujii, Motoi Odani, Tadao Akizawa
• Journal: Clinical nephrology (Clin Nephrol) Vol. 88 Issue 2 Pg. 68-78 (08 2017) ISSN: 0301-0430 [Print] Germany
• PMID: 28671062 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Parathyroid Hormone
• Peptides
• Fibroblast Growth Factors
• etelcalcetide hydrochloride
• Fibroblast Growth Factor-23
• Calcium

Topics

• Adult
• Aged
• Calcium (blood)
• Electrocardiography
• Female
• Fibroblast Growth Factor-23
• Fibroblast Growth Factors (blood)
• Humans
• Hyperparathyroidism, Secondary (blood, drug therapy, physiopathology)
• Injections, Intravenous
• Male
• Middle Aged
• Parathyroid Hormone (blood)
• Peptides (adverse effects, immunology, therapeutic use)
• Renal Dialysis (adverse effects)