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

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

Timeline

Start

2024-08-26

Primary completion

2025-09-11

Completion

2025-09-11

Outcome

Missed primary endpoint

release “Fas 2b-studien POINTER visade ingen statistiskt signifikant skillnad mellan RMC-035 och placebo för det primära effektmåttet” guardtherapeutics.com ↗

Publications

• Zarbock A, Strauss C, Laflamme M, Myjavec A, Bohm J, Burkert J, Mazer CD, de Varennes B, Iglesias AG, Matschke K, Larsson TE, Reusch M; POINTER study group. POINTER: study protocol for a phase 2b, randomised, placebo-controlled, double-blind, parallel group dose-finding clinical study to evaluate the efficacy of RMC-035 on renal function and safety, in participants at high risk for kidney injury, following open-chest cardiac surgery. Trials. 2025 Oct 28;26(1):449. doi: 10.1186/s13063-025-09124-x.

Drugs

Indications

No indication recorded.