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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 May 2026

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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

  • 30 Apr 2026 Primary endpoint has not been met. (Hierarchical composite of the following outcomes: death, incidence of AKI requiring dialysis, days in ICU, and 30-day cardiopulmonary readmission)
  • 30 Apr 2026 According to a Renibus Therapeutics media release, data from this trial presented at the 106th American Association for Thoracic Surgery (AATS) Annual Meeting, taking place May 2-5, 2026 in Chicago, IL.
  • 30 Apr 2026 Results presented at Renibus Therapeutics media release.

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