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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510658-28-00

Acronym

24-ROS-07

Enrollment

124

Registered

2024-08-05

Start date

2024-09-24

Completion date

2025-09-05

Last updated

2025-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Loss of renal function following cardiac surgery

Brief summary

Change from baseline in eGFR based on SCr at Day 90 (pooled low and high dose levels)

Detailed description

Occurrence of MAKE (and each MAKE component) at Day 90 (pooled low and high doses, and by each dose level), Change from Baseline in eGFR based on SCr at Day 90 (low and high doses, respectively)

Interventions

DRUGRMC-035

DRUGAn aqueous clear

DRUGcolorless to slightly yellow solution.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline in eGFR based on SCr at Day 90 (pooled low and high dose levels)	—

Secondary

Measure	Time frame
Occurrence of MAKE (and each MAKE component) at Day 90 (pooled low and high doses, and by each dose level), Change from Baseline in eGFR based on SCr at Day 90 (low and high doses, respectively)	—

Countries

Czechia, Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026