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A Phase I/II study of ONO-5163 in patients with secondary hyperparathyroidism under maintenance dialysis (ONO-5163-02)

Trial Profile

A Phase I/II study of ONO-5163 in patients with secondary hyperparathyroidism under maintenance dialysis (ONO-5163-02)

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 01 Jul 2022

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At a glance

  • Drugs Etelcalcetide (Primary)
  • Indications Secondary hyperparathyroidism
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
  • Sponsors Ono Pharmaceutical
  • Most Recent Events

    • 30 Jul 2020 Results of meta-analysis of four studies (NCT01785849, NCT01254565, JapicCTI142664 & JapicCTI121978) assessing efficacy and safety of etelcalcetide for the treatment of secondary hyperparathyroidism (SHPT) in patients receiving hemodialysis, published in the Clinical Nephrology.
    • 01 Aug 2017 Results (n=24) of phase II of the study assessing efficacy, published in the Clinical Nephrology.
    • 29 Jun 2016 Planned number of patients changed from 55 to 61.
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