SeaStar Medical has announced that Mayo Clinic is now cleared to enrol subjects in the company’s NEUTRALIZE-AKI pivotal trial, increasing the number of activated sites to 15.
The NEUTRALIZE-AKI pivotal trial is evaluating the safety and efficacy of SeaStar Medical’s proprietary therapeutic selective cytopheretic device (SCD) in 200 adults with acute kidney injury (AKI) in the intensive care unit (ICU) receiving continuous renal replacement therapy (CRRT).
SCD employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during CRRT and reduces the hyperinflammatory milieu including the cytokine storm. The device previously received US Food and Drug Administration (FDA) breakthrough device designation for adults with AKI.
“We are thrilled to activate another large academic centre to our study,” said Kevin Chung, chief medical officer of SeaStar Medical. “Enrolment in the trial currently stands at 76 with six subjects enrolled since the first of the year. We look forward to our next major milestone of reaching our 100th subject for our interim analysis soon.”
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. Secondary endpoints 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.
SeaStar Medical plans to conduct an interim analysis at the trial’s 90-day primary endpoint with the first 100 subjects. Given the current pace of enrolment, the company anticipates a Data Safety Monitoring Board (DSMB) recommendation on the interim results by mid-2025.