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An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Phase 3 Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21 Compared With Sevelamer Carbonate in Dialysis Patients With Hyperphosphataemia. Extension Study for Protocol PA-CL-05A

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Trial Profile

An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Phase 3 Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21 Compared With Sevelamer Carbonate in Dialysis Patients With Hyperphosphataemia. Extension Study for Protocol PA-CL-05A

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Sucroferric oxyhydroxide (Primary) ; Sevelamer
  • Indications Hyperphosphataemia
  • Focus Therapeutic Use
  • Sponsors Vifor

    • Most Recent Events

    • 29 May 2018 Results of post-hoc analysis from both parent (NCT01324128) and extension (NCT01464190) study assessing the effects serum phosphate control and FGF-23 levels with sucroferric oxyhydraoxide and sevelamer on CKD-MBD parameters among dialysis patients who completed 1 year of treatment with sucroferric oxyhydroxide or sevelamer published in the Nephrology Dialysis Transplantation
    • 23 Feb 2017 Results (n=1055) of both parent and extension study assessing one year efficacy and safety published in the Nephrology Dialysis Transplantation.
    • 23 Jun 2016 Results of post-hoc analysis of patients who completed 52 weeks of continuous treatment (n = 549) from this trial and its parent trial (NCT01324128) published in the Nephrology Dialysis Transplantation
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