SeaStar Medical updates subject enrollment in its pivotal trial with the Selective Cytopheretic device in adults with acute kidney injury.
SeaStar Medical Holding Corporation announces enrollment of 12 subjects in the NEUTRALIZE-AKI pivotal clinical trial evaluating the safety and efficacy of its patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT)
“Over the past six weeks we have enrolled five subjects in this clinical trial while also continuing progress in activating additional clinical sites,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “We are grateful to the dedicated investigators and their research staff who are working diligently to help validate the efficacy and safety of the SCD in this vulnerable population.”
“We look forward to providing periodic updates on patient enrollment and site activations as this important trial progresses,” said Eric Schlorff, CEO of SeaStar Medical. “We believe the more than 200,000 U.S. adult patients each year with AKI who require CKRT deserve a better treatment option. To that end, we are committed to advancing our pivotal clinical trial with the goal of saving lives and improving quality of life by eliminating dialysis dependency through renal recovery.”
SeaStar Medical expects to receive FDA approval for its SCD Pediatric (SCD-PED) under a Humanitarian Device Exemption (HDE) for use in children weighing 10 kilograms or more with AKI and sepsis or a septic condition requiring continuous CKRT anytime within the next 30 to 45 days and to commence commercialization of the SCD-PED in Q1 2024.
About the NEUTRALIZE-AKI Pivotal Trial : The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective CytopheretIic Device - a randomiZEd clinical trial in Acute Kidney Injury) pivotal trial is expected to enroll up to 200 patients. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with SCD in addition to CKRT as the standard of care, compared with the control group receiving only CKRT 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.
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