Nihon Toseki Igakkai Zasshi
Online ISSN : 1883-082X
Print ISSN : 1340-3451
ISSN-L : 1340-3451
Protocol for etelcalcetide hydrochloride treatment
Akito ItoTakaya AbeShuhei IshiiTomohiko MatsuuraJun SugimuraNariyuki SasakiYumiko TakasawaTetsuo KatoWataru Obara
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2019 Volume 52 Issue 3 Pages 151-157

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Abstract

After the initial administration of etelcalcetide hydrochloride (Etel), its dosage might be adjusted depending on the attending physician’s view. Therefore, at dialysis facilities, where patients are managed by multiple doctors, the management of secondary hyperparathyroidism (SHPT) with Etel can take many different courses. In this study, an Etel administration protocol was devised to prevent variations in Etel-based SHPT management within the same dialysis facility, and its effects were examined. The protocol was devised in accordance with the findings of domestic phase III trials of Etel. Twenty-two subjects were enrolled. The study period lasted for 28 weeks, starting from the administration of the first dose of Etel. During the study, 5 subjects dropped out, including 2 patients who died because of other factors, and so 17 subjects completed the study. The mean dose of Etel decreased significantly from 5 mg at the start of the study to 4.4±1.7 mg at the end of the study (p=0.0084). In addition, by the end of the study the proportion of patients whose intact-parathyroid hormone levels were controlled at ≤240 pg/mL had significantly increased from 12 (54.5%) out of 22 subjects to 15 (88.2%) out of 17 subjects (p=0.0238). No new side effects developed during the study period. This Etel administration protocol might enable physicians to manage and control SHPT more effectively.

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© 2019 The Japanese Society for Dialysis Therapy
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