Trial now over 60% enrolled with 125 of 200 anticipated patients
SeaStar Medical Holding Corporation, a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, announced that it has successfully reached enrollment of 125 patients in the NEUTRALIZE-AKI pivotal clinical trial. Additionally, it has activated Methodist Hospital Metropolitan of San Antonio, Texas, as its 16th clinical trial site.
The company also reported that it remains on track to receive results from the per protocol prespecified interim analysis of the first 100 patients in the trial in the third quarter of 2025. The analysis is being conducted by the trial’s independent Data Safety Monitoring Review Board (DSMB). The company intends to disclose to its stakeholders only the top-line decision from the analysis by the DSMB to preserve the integrity to the ongoing trial.
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“We are very pleased to reach this new enrollment milestone in the NEUTRALIZE-AKI pivotal trial,” stated Kevin Chung, MD, Chief Medical Officer of Sea Star Medical. “We are also thrilled to welcome Methodist Hospital Metropolitan as a key addition to our clinical trial sites. Its affiliate, Methodist Hospital, is one of our highest enrolling sites, and we believe their shared research teams and recruitment efforts should enable expedited recruitment and enrollment of patients in the NEUTRALIZE-AKI pivotal trial.”
Dr. Chung continued, “With respect to our upcoming interim analysis, the NEUTRALIZE-AKI pivotal trial is rigorously powered to detect a true efficacy signal, and confirming safety remains a top priority. This interim analysis seeks to validate the therapy’s safety profile and efficacy potential – critical factors in supporting a DSMB recommendation to proceed to full trial completion.”
A complete list of the NEUTRALIZE-AKI pivotal clinical trial sites can be viewed on ClinicalTrials.gov and includes notable institutions, such as Cleveland Clinic, Mayo Clinic, and Stanford Medical Center. The 16 clinical trial sites that are participating in the trial are clearly aware of the high unmet need of patients with AKI requiring CRRT. SeaStar Medical is grateful for their active participation in the trial.
About the NEUTRALIZE-AKI Pivotal Clinical Trial
NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) is a pivotal trial that is expected to enroll up to 200 adult patients with AKI requiring CRRT. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with SCD in addition to CRRT as the standard of care, compared with the control group receiving only CRRT standard of care. The trial has enrolled 125 of 200 total anticipated patients. The per protocol interim analysis of the first 100 patients on the trial’s 90-day primary endpoint is being conducted by the trial’s independent DSMB. Secondary endpoints of the trial include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90 and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome.
About the NEUTRALIZE-AKI Interim Analysis
The NEUTRALIZE-AKI pivotal clinical trial protocol specifies that an interim analysis will be conducted by the independent DSMB on the primary endpoint of the trial when approximately 50% of patients (100 patients) achieve 90-day follow-up. The protocol specifies a very low probability of stopping the trial for efficacy at the interim analysis and would also require concurrence by the FDA. It also specifies that the DSMB may recommend a sample size re-estimation to maintain a statistically significant CRRT plus SCD therapy effect by the end of the study, based on the interim results. And while SeaStar Medical believes it is unlikely, the DSMB could also recommend stopping the trial for futility.
About Acute Kidney Injury (AKI) and Hyperinflammation
AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as COVID-19, sepsis, severe trauma and surgery. AKI can cause hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, these patients may face chronic kidney disease or end-stage renal disease requiring dialysis, among other complications. Hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation.
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Source- GlobeNewswire
