NCT04829916

A Study to Evaluate RMC-035 in Subjects Undergoing Cardiac Surgery

A Phase 1b, Randomised, Double-Blind, Parallel Treatment Group Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RMC-035 in Subjects Undergoing Non-Emergent On-Pump Coronary Artery Bypass Graft and/or Valve Surgery

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Guard Therapeutics AB · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the clinical study is to assess safety, tolerability and pharmacokinetics of RMC-035 for the prevention and treatment of acute kidney injury (AKI) in patients undergoing cardiac surgery.

Detailed description

This is a study with two parallel treatment groups where subjects are randomized to receive RMC-035 or a matching placebo in a double-blind fashion. The study will comprise of a screening visit, followed by CABG and/or valve replacement on Day 1, double-blind treatment period and a follow-up period up to Day 30.

Conditions

• Acute Kidney Injury (AKI)

Interventions

Type	Name	Description
DRUG	RMC-035	Multiple dosing during 48 hours following cardiac surgery
DRUG	Placebo	Multiple dosing during 48 hours following cardiac surgery

Timeline

• Start date: 2021-03-16
• Primary completion: 2021-07-15
• Completion: 2021-07-15
• First posted: 2021-04-02
• Last updated: 2024-04-23
• Results posted: 2023-12-04

Locations

1 site across 1 country: Germany