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A Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Proof of Concept, and Dose-Finding Adaptive Phase 2a/2b Study to Investigate the Safety, Tolerability and Efficacy and Effect on Quality of Life of Human Recombinant Alkaline Phosphatase in the Treatment of Patients With Sepsis-Associated Acute Kidney Injury

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Proof of Concept, and Dose-Finding Adaptive Phase 2a/2b Study to Investigate the Safety, Tolerability and Efficacy and Effect on Quality of Life of Human Recombinant Alkaline Phosphatase in the Treatment of Patients With Sepsis-Associated Acute Kidney Injury

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 24 Oct 2018

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At a glance

  • Drugs Alkaline phosphatase (Primary)
  • Indications Acute kidney injury
  • Focus Proof of concept; Registrational; Therapeutic Use
  • Acronyms STOP-AKI
  • Sponsors AM-Pharma
  • Most Recent Events

    • 24 Oct 2018 Results published in the JAMA: the Journal of the American Medical Association
    • 24 Oct 2018 Primary endpoint has not been met. (Measured creatinine clearance (based on urine volume and creatinine concentrations)), according to an AM-Pharma media release.
    • 24 Oct 2018 According to an AM-Pharma media release, results from this study will be presented at the European Society of Intensive Care Medicine (ESICM) and at the American Society of Nephrology Kidney Week (Oct 2018).
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