Table of Contents
- Clinical trial overview
- Who was studied
- Treatment and comparison
- Trial phase and size
- What was measured
- What the trial aimed to find
Clinical trial overview
The available study of Rmc-035 was a completed Phase 2 interventional trial in people undergoing open-chest cardiac surgery.[1] The study focused on loss of renal function following cardiac surgery, which means a drop in kidney performance after heart surgery.[1]
Who was studied
The trial enrolled participants who were having open-chest cardiac surgery and were at high risk of kidney injury.[1] This target group matters because surgery can sometimes affect the kidneys, so the study looked at people most likely to benefit from kidney protection.[1]
Treatment and comparison
Participants received either Rmc-035 or a placebo, which was described as an aqueous clear, colorless to slightly yellow solution.[1] A placebo is a comparison treatment that helps researchers see whether the study drug has a real effect.[1]
Trial phase and size
This was a Phase 2b dose finding study, so the researchers were not only testing whether the treatment may help, but also looking for the best dose.[1] The study enrolled 180 participants.[1]
What was measured
The main outcome was the change from baseline in eGFR based on serum creatinine at Day 90, using pooled low and high dose levels.[1] eGFR is an estimate of kidney filtering ability, and serum creatinine is a blood test used to help calculate it.[1]
What the trial aimed to find
The study aimed to evaluate the efficacy of Rmc-035 versus placebo on renal function at Day 90 and to identify the optimal dose for protecting long-term kidney function in patients undergoing cardiac surgery who are at high risk of kidney injury.[1] In simple terms, the researchers wanted to know whether the treatment could help the kidneys recover better after surgery and which dose might work best.[1]
