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A Phase 2b, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Dose-Finding Study to Evaluate the Efficacy on Renal Function and Safety of RMC-035 in Participants at High Risk for Kidney Injury Following Open-Chest Cardiac Surgery

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Trial Profile

A Phase 2b, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Dose-Finding Study to Evaluate the Efficacy on Renal Function and Safety of RMC-035 in Participants at High Risk for Kidney Injury Following Open-Chest Cardiac Surgery

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 01 Dec 2025

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At a glance

  • Drugs RMC 035 (Primary)
  • Indications Acute kidney injury
  • Focus Therapeutic Use
  • Acronyms POINTER
  • Sponsors Guard Therapeutics

Most Recent Events

  • 26 Oct 2025 According to a Guard Therapeutics media release, the complete dataset from this study is expected to be available within two weeks. Also company will host an open web call on October 27 at 2:00 p.m. CET to discuss the study results and respond to questions.
  • 26 Oct 2025 Primary endpoint (Change from baseline in eGFR at Day 90 (the two arms of RMC-035 pooled compared against placebo)) has not been met, according to Guard Therapeutics Media Release.
  • 26 Oct 2025 Results were presented in the Guard Therapeutics Media Release.

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