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Phase 3 Study of SK-1403 ; Double-blinded Parallel Group in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis

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Trial Profile

Phase 3 Study of SK-1403 ; Double-blinded Parallel Group in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Oct 2023

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At a glance

  • Drugs Upacicalcet (Primary)
  • Indications Secondary hyperparathyroidism
  • Focus Registrational; Therapeutic Use
  • Sponsors Sanwa Kagaku Kenkyusho

Most Recent Events

  • 01 Oct 2023 Results assessing the efficacy and safety of upacicalcet in patients with secondary hyperparathyroidism receiving undergoing hemodialysis, published in the Clinical Journal of The American Society of Nephrology: CJASN.
  • 01 Mar 2022 According to a Pathalys Pharma media release, Upacicalcet was granted Marketing Authorization in Japan in 2021, under the brand name UPASITA, based on a phase 3, 24-week double-blind, placebo-controlled dose-titration study and a second phase 3, 52-week open-label, dose-titration study.
  • 06 Mar 2020 Status changed from active, no longer recruiting to completed.

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