Table of Contents
- Trial overview
- Who can join the study
- Study design and treatment groups
- What the study is measuring
- What this trial means for patients
Trial overview
The available trial is called EASE-AKI and is studying SP16-3M in people with chronic kidney disease who are having elective cardiac surgery with a heart-lung machine.[1] The study is Phase 2, which means it is looking more closely at whether the treatment may help and whether it appears safe in this group.[1]
This is an interventional study, so participants receive a study treatment and the researchers compare outcomes between groups.[1] The trial status is Authorised, and the planned enrollment is 120 participants.[1]
Who can join the study
The trial is designed for at-risk subjects with chronic kidney disease who are going to planned heart surgery using a heart-lung machine.[1] The brief summary says the target group includes participants with CKD 2-3b, which means a moderate range of long-term kidney disease.[1]
The listed conditions for the study are Chronic Kidney Disease, Valvular Disease, and Cardiovascular Disease.[1] In simple terms, this means the trial is focused on people having heart surgery who already have kidney problems and related heart or blood vessel disease.[1]
Study design and treatment groups
The trial is described as prospective, randomized, double-blind, and placebo-controlled.[1] Prospective means the study follows people forward in time, randomized means participants are assigned by chance, double-blind means neither the participants nor the study team know who gets which treatment, and placebo-controlled means one group receives a comparison treatment that does not contain the active study drug.[1]
The intervention list shows a comparison between a subcutaneous injection of a placebo-like drug entry and SP16-3M given by subcutaneous injection at 12 mg.[1] The study title also states that the trial is testing efficacy and safety for preventing acute kidney injury after surgery.[1]
What the study is measuring
The main safety endpoint is the frequency of adverse events and serious adverse events within 72 hours after the index surgery.[1] This means the researchers are watching for any medical problems after the operation, especially in the first three days.[1]
The main efficacy endpoint is the number of participants who develop CSA-AKI during the hospital stay, defined as KDIGO stage 1 or higher.[1] CSA-AKI means kidney injury linked to cardiac surgery, and KDIGO is the rule set used to grade how serious the kidney injury is.[1]
The brief summary also says the goal is to see whether SP16-3M can prevent CSA-AKI as defined by KDIGO criteria in participants with CKD 2-3b undergoing planned cardiac surgery.[1]
What this trial means for patients
For patients, this study is mainly about finding out whether SP16-3M can lower the risk of kidney injury around the time of heart surgery.[1] The study is focused on a specific high-risk group, so the results may be most useful for people with chronic kidney disease who need elective cardiac surgery.[1]
Because the trial is still in Phase 2, it is not a final proof of benefit, but an important step to learn more about safety and possible effect in the target population.[1]
