Table of Contents
- Trial overview
- Who was studied
- Study design and phase
- Main outcomes measured
- What the study aimed to find
Trial overview
The source data describes one interventional study of RO7288817 in patients at moderate to high risk for cardiac surgery associated acute kidney injury (CSA-AKI).[1] The study compared RO7288817 with placebo, which is a look-alike treatment without the active study medicine.[1] The trial is listed as completed and enrolled 390 people.[1]
Who was studied
This study focused on patients having heart surgery who were considered at moderate to high risk for kidney injury after the operation.[1] In simple terms, the trial looked at people more likely than usual to develop acute kidney injury, which means a sudden loss of kidney function.[1]
The source data does not give more detailed entry rules, such as age limits or other medical conditions, so the main target group can only be described as patients at higher risk for CSA-AKI.[1]
Study design and phase
The trial was a Phase 2 study.[1] Phase 2 trials are usually done to learn more about whether a treatment may help and to keep checking safety in a larger group than early-stage studies.[1]
The study was designed to compare RO7288817 with placebo after heart surgery.[1] The source data also lists oral dosing entries, but it does not provide a clear, patient-friendly treatment schedule or full group details, so those parts cannot be described further from the available information.[1]
Main outcomes measured
The main outcome was MAKE90, which stands for major adverse kidney events within 90 days after surgery.[1] This outcome combines three serious events: death, need for dialysis, or a 25% or greater decline in eGFR, which is an estimate of kidney filtering function, by day 90 after surgery.[1]
This type of combined outcome helps researchers see whether the study treatment may lower the overall risk of important kidney-related problems after surgery.[1]
What the study aimed to find
The brief summary says the study aimed to evaluate the efficacy of RO7288817 compared with placebo for preventing major adverse kidney events at 90 days after surgery.[1] It also aimed to evaluate safety.[1]
In patient terms, the trial was trying to learn whether RO7288817 could help protect kidney health after heart surgery in people who were already at higher risk for kidney injury.[1]
