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Pharmacokinetics of recombinant human soluble thrombomodulin in disseminated intravascular coagulation patients with acute renal dysfunction

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Title: Pharmacokinetics of recombinant human soluble thrombomodulin in disseminated intravascular coagulation patients with acute renal dysfunction
Authors: Hayakawa, Mineji Browse this author →KAKEN DB
Kushimoto, Shigeki Browse this author →KAKEN DB
Watanabe, Eizo Browse this author
Goto, Koji Browse this author
Suzuki, Yasushi Browse this author
Kotani, Toru Browse this author
Kiguchi, Takeyuki Browse this author
Yatabe, Tomoaki Browse this author
Tagawa, Jun Browse this author
Komatsu, Fumiyo Browse this author
Gando, Satoshi Browse this author →KAKEN DB
Keywords: Plasma concentration
disseminated intravascular coagulation
renal dysfunction
Issue Date: 2017
Publisher: Schattauer GmbH
Journal Title: Thrombosis and haemostasis
Volume: 117
Issue: 5
Start Page: 851
End Page: 859
Publisher DOI: 10.1160/TH16-07-0547
Abstract: Recombinant human soluble thrombomodulin (ART-123) is a novel anticoagulant for patients with disseminated intravascular coagulation (DIC). It is widely used in clinical settings throughout Japan. Furthermore, a global Phase 3 study is currently being conducted. In healthy subjects, ART-123 is excreted mainly via the kidneys. Therefore, ART-123 dose decrease was recommended in DIC patients with severe renal dysfunction. However, the pharmacokinetics of ART-123 in DIC patients with severe acute renal dysfunction has not been elucidated. In an open-label, multicentre, prospective, clinical pharmacological study, we investigated the pharmacokinetics and safety of ART-123 upon repeated administration to DIC patients. ART-123 was administered to patients at a dose of 130 or 380 U/kg/day for six consecutive days. Plasma concentrations of ART-123 were measured at 21 time points until eight days after the final administration. Urinary ex-cretion rates during the first 24 hours (h) were calculated. Patient renal functions were evaluated by measuring 24-h creatinine clearance (Ccr). Forty-three patients were enrolled in the present study. The urinary excretion rates of ART-123 correlated closely with 24-h Ccr. Total body clearance of ART-123 was also weakly related with 24-h Ccr. However, the plasma concentrations of ART-123 were not considerably different among patients with different renal function. Two patients had subcutaneous haemorrhage as an adverse event related to ART-123. In conclusion, plasma concentrations of ART-123 may not be different among patients with different renal functions. ART-123 was well tolerated in these patients.
Type: article
Appears in Collections:医学院・医学研究院 (Graduate School of Medicine / Faculty of Medicine) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

Submitter: 早川 峰司

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