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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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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: Recruiting
Phase of Trial: Phase II

Latest Information Update: 27 Mar 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

  • 25 Mar 2025 According to a Guard Therapeutics media release, two-thirds of the approximately 160 planned patients have now been enrolled in this study.
  • 27 Feb 2025 According to a Guard Therapeutics media release, Patient recruitment is expected to be completed in Q3 2025, with the overall study results anticipated approximately six months after recruitment is finalized.
  • 27 Feb 2025 According to a Guard Therapeutics media release, the company announces positive outcome from first independent safety data review. And, in the second quarter of 2025, comapny expect to present the results of the next safety review, which will include data from about two-thirds of the total planned patients.

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