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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery

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Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 10 Mar 2025

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At a glance

  • Drugs Iron-sucrose/tin-protoporphyrin (Primary)
  • Indications Acute kidney injury
  • Focus Registrational; Therapeutic Use
  • Acronyms PROTECT
  • Sponsors Renibus Therapeutics

    • Most Recent Events

    • 07 Mar 2025 Planned number of patients changed from 400 to 450.
    • 03 Oct 2024 According to a Renibus Therapeutics media release, top-line data expected in the second quarter of 2025.
    • 03 Oct 2024 According to a Renibus Therapeutics media release, company announced poster presentations of promising data results on its first-in-class Phase 3 program, RBT-1, at the AMCP Nexus 2024 Meeting, taking place October 14-17, 2024 in Las Vegas, NV.

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