Trial Profile

A pivotal phase 3 study of RMC-035

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 02 Feb 2025

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At a glance

Drugs RMC 035 (Primary)
Indications Acute kidney injury
Focus Adverse reactions; Registrational; Therapeutic Use

Most Recent Events

22 Jan 2025 According to a Guard Therapeutics media release, the company announced the formation of a new Scientific Advisory Committee comprising seven globally recognized experts in nephrology and drug development. The committee will play a pivotal role in advising on the company's late-phase development strategy and the design of the upcoming Phase 3 trial for RMC-035, a kidney protective therapy intended for use in open-heart surgery.
17 Sep 2024 According to a Guard Therapeutics media release, Major Adverse Kidney Events (MAKE) is the expected primary efficacy endpoint in this pivotal phase 3 study as required by regulatory authorities.
29 Jan 2024 New trial record

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