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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: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Aug 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

  • 01 Aug 2025 Status changed from active, no longer recruiting to completed.
  • 24 Apr 2025 According to a Renibus Therapeutics media release, company announced the completion of enrollment, the trial enrolled 423 patients across 40 trial sites in the United States (US) and Canada. Topline results from the study are anticipated in third quarter of 2025.
  • 24 Apr 2025 Status changed from recruiting to active, no longer recruiting.

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