NCT05126303

Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery

A Phase 2, Randomized, Placebo-Controlled, Double-Blind, Adaptive, Parallel Group Clinical Study to Evaluate the Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 177 (actual)
• Sponsor: Guard Therapeutics AB · Industry
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates RMC-035 compared to placebo for the prevention of acute kidney injury (AKI) in subjects who are at high risk for AKI following cardiac surgery. Half of the subjects will receive RMC-035 and the other half will receive placebo.

Detailed description

This is a Phase 2, randomized, double-blind, adaptive, parallel group clinical study that will evaluate RMC-035 compared to placebo in subjects at high risk for acute kidney injury (AKI) following cardiac surgery. Subjects are randomized in a 1:1 ratio.

Conditions

• Acute Kidney Injury

Interventions

Type	Name	Description
DRUG	RMC-035	Concentrate for Solution for Infusion
DRUG	Placebo	Concentrate for Solution for Infusion

Timeline

• Start date: 2022-03-31
• Primary completion: 2023-04-15
• Completion: 2023-07-12
• First posted: 2021-11-19
• Last updated: 2024-05-16
• Results posted: 2024-05-16

Locations

29 sites across 5 countries: United States, Canada, Czechia, Germany, Spain

Regulatory

• FDA-regulated drug study