NCT06475274

A Phase 2b Dose Finding Study of RMC-035 in Participants Undergoing Open-chest Cardiac Surgery

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: Phase 2
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Guard Therapeutics AB · Industry
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to identify the optimal dose of RMC-035 for protection of long-term renal function in adult patients undergoing cardiac surgery who are at high risk of kidney injury. It will also learn about the safety of RMC-035. The main question it aims to answer is: * Does RMC-035 protect the function of kidneys after surgery? * Is RMC-035 safe? Researchers will compare RMC-035 in high dose, RMC-035 in low dose and placebo to see if * Kidney function better for participants treated with any of the RMC-035 doses? * What medical problems do participants have when receiving RMC-035? Participants will * Receive 3 doses of RMC-035 or placebo: at the beginning of surgery, end of surgery and 24h after surgery * Have extra checkups and tests during their hospital stay * Visit the clinic at two extra occasions at 60 days and 90 days after surgery for checkups and tests

Conditions

• Kidney Injury Following Open-Chest Cardiac Surgery

Interventions

Type	Name	Description
DRUG	RMC-035	Protein, a recombinant variant of A1M. Concentrate for solution for infusion.
DRUG	Placebo	Identical to RMC-035 intervention devoid of the active substance.

Timeline

• Start date: 2024-08-26
• Primary completion: 2025-09-11
• Completion: 2025-09-11
• First posted: 2024-06-26
• Last updated: 2025-10-02

Locations

19 sites across 4 countries: Canada, Czechia, Germany, Spain

Regulatory

• FDA-regulated drug study