In short
Clinical trials are studying Rmc-035 in people having open-chest cardiac surgery. These trials look at whether Rmc-035 can help protect kidney function, find the best dose, and measure how well it works compared with placebo.
Key points
- Clinical trials of Rmc-035 are studying people having open-chest cardiac surgery who are at risk of kidney problems after surgery. The main trial listed is a Phase 2 study with 180 participants. It compares Rmc-035 with placebo and looks at kidney function at Day 90. The trial also aims to find the best dose for protecting long-term kidney function. The main outcome is the change in eGFR, which is a measure of how well the kidneys filter blood.
Clinical trial overview
The available study of Rmc-035 was a completed Phase 2 interventional trial in people undergoing open-chest cardiac surgery. The study focused on loss of renal function following cardiac surgery, which means a drop in kidney performance after heart surgery.
Who was studied
The trial enrolled participants who were having open-chest cardiac surgery and were at high risk of kidney injury. This target group matters because surgery can sometimes affect the kidneys, so the study looked at people most likely to benefit from kidney protection.
Treatment and comparison
Participants received either Rmc-035 or a placebo, which was described as an aqueous clear, colorless to slightly yellow solution. A placebo is a comparison treatment that helps researchers see whether the study drug has a real effect.
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. The study enrolled 180 participants.
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. eGFR is an estimate of kidney filtering ability, and serum creatinine is a blood test used to help calculate it.
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. 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.