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An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 and Sevelamer Carbonate (Renvela) in Chinese CKD Patients With Hyperphosphataemia

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Trial Profile

An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 and Sevelamer Carbonate (Renvela) in Chinese CKD Patients With Hyperphosphataemia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Jun 2023

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At a glance

  • Drugs Sucroferric oxyhydroxide (Primary) ; Sevelamer
  • Indications Hyperphosphataemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Vifor Fresenius Medical Care Renal Pharma
  • Most Recent Events

    • 30 Apr 2021 According to a Vifor Fresenius Medical Care Renal Pharma media release, the company intends to submit the Chinese New Drug Application to the National Medical Products Administration's CDE at the end of 2021.
    • 30 Apr 2021 Results presented in the Vifor Fresenius Medical Care Renal Pharma Media Release.
    • 30 Apr 2021 Primary endpoint (Serum phosphorus (mmol/l )) has been met, according to a Vifor Fresenius Medical Care Renal Pharma media release.

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