Phase III clinical trial of OPF-102 in renal failure patients : Aiming at safer intravenous phosphorus repletion

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  • Akiba Takashi
    Department of Blood Purification Therapy, Tokyo Women's Medical University (medical advisor)
  • Tamura Teiichi
    Division of Nephrology, Department of Internal Medicine, Yokosuka Mutual Aid Hospital, Federation of National Public Service Personnel Mutual Aid Associations (investigator)
  • Kamata Kouju
    Division of Nephrology, Department of Internal Medicine, Kitasato University Hospital, The Kitasato Institute (investigator)
  • Minakuchi Jun
    Division of Nephrology, Department of Internal Medicine, Kawashima Hospital, Kawashima Medical Corporation (investigator)
  • Matsui Noriaki
    Department of Internal Medicine, Tsuchiura Kyodo General Hospital (investigator)

Bibliographic Information

Other Title
  • 腎不全患者を対象としたＯＰＦ－１０２の臨床試験（第ＩＩＩ相）　　‐より安全な経静脈的リン補給に向けて‐
  • 腎不全患者を対象としたOPF-102の臨床試験(第3相)--より安全な経静脈的リン補給に向けて
  • ジンフゼン カンジャ オ タイショウ ト シタ OPF 102 ノ リンショウ シケン ダイ3ソウ ヨリ アンゼン ナ ケイ ジョウミャクテキ リン ホキュウ ニ ムケテ
  • Phase III clinical trial of OPF-102 in renal failure patients
  • : Aiming at safer intravenous phosphorus repletion
  • ―より安全な経静脈的リン補給に向けて―

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Abstract

The conventional method of treating phosphorus deficiency by dipotassium phosphate injection as a phosphorus supplement may induce hyperkalemia. To address this challenge, Otsuka Pharmaceutical Factory, Inc. has developed an electrolyte solution (sodium phosphate injection [OPF-102]) that substitutes sodium phosphates for their potassium counterparts in the formulation. This solution can be used when there is a risk of high serum potassium concentrations. In this study, we evaluated the effectiveness and safety of OPF-102 for correction of serum phosphorus levels when administered to patients with renal failure who were undergoing hemodialysis and required phosphorus repletion. We administered OPF-102 intravenously to 10 subjects. In all subjects, the serum phosphorus concentrations normalized after administration of OPF-102. The patients' serum potassium concentrations, which fluctuated before administration of OPF-102, were not affected. In addition, there were no adverse events requiring clinical intervention during administration of OPF-102. OPF-102 is expected to be useful as a phosphorus supplement in clinical situations with a potential risk of inducing a high serum potassium concentrations.

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