In short
Clinical trials are investigating SP16-3M in people with chronic kidney disease who are having planned cardiac surgery with a heart-lung machine. These studies are looking at safety and whether SP16-3M can help prevent acute kidney injury during the hospital stay.
Key points
- Clinical trials are investigating SP16-3M in people with chronic kidney disease who are having planned cardiac surgery with a heart-lung machine. The study is a Phase 2, interventional trial and is authorised. Researchers are mainly looking at whether SP16-3M can prevent cardiac surgery-associated acute kidney injury during the hospital stay. They are also measuring safety by tracking adverse events and serious adverse events within 72 hours after surgery. The planned study size is 120 participants.
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. 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.
This is an interventional study, so participants receive a study treatment and the researchers compare outcomes between groups. The trial status is Authorised, and the planned enrollment is 120 participants.
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. The brief summary says the target group includes participants with CKD 2-3b, which means a moderate range of long-term kidney disease.
The listed conditions for the study are Chronic Kidney Disease, Valvular Disease, and Cardiovascular Disease. 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.
Study design and treatment groups
The trial is described as prospective, randomized, double-blind, and placebo-controlled. 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.
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. The study title also states that the trial is testing efficacy and safety for preventing acute kidney injury after surgery.
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. This means the researchers are watching for any medical problems after the operation, especially in the first three days.
The main efficacy endpoint is the number of participants who develop CSA-AKI during the hospital stay, defined as KDIGO stage 1 or higher. CSA-AKI means kidney injury linked to cardiac surgery, and KDIGO is the rule set used to grade how serious the kidney injury is.
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.
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. 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.
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.