Mayo Clinic has joined SeaStar Medical as the 15th site authorised to enrol subjects for the company’s pivotal NEUTRALIZE-AKI trial to treat adults with acute kidney injury (AKI).
The trial is assessing the efficacy and safety of the company’s selective cytopheretic device (SCD) in conjunction with continuous renal replacement therapy (CRRT).
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The trial aims to enrol 200 adult subjects in intensive care units (ICUs) who are undergoing CRRT for AKI.
SeaStar Medical chief medical officer Kevin Chung said: “We are thrilled to activate another large academic centre to our study.
“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 primary endpoint of the study is a composite of 90-day mortality or dialysis dependency of subjects who received treatment with SCD in addition to CRRT, against a control group receiving only CRRT.
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By GlobalDataSecondary goals include 28-day mortality, ICU-free days in the initial 28 days, major adverse kidney events at day 90, and dependency on dialysis at one year, the company noted.
SCD therapy’s effectiveness in AKI subjects with sepsis and acute respiratory distress syndrome will also be analysed through subgroup studies.
An interim analysis is planned by the company after the first 100 subjects reach the 90-day primary endpoint.
It also anticipates a recommendation from the Data Safety Monitoring Board (DSMB) on these interim outcomes by the middle of this year, given the current enrolment rate.
Leveraging an immunomodulating technology, the SCD targets proinflammatory neutrophils and monocytes during CRRT, aiming to decrease the hyperinflammatory state, including the cytokine storm.
This approach is claimed to improve organ recovery and potentially eliminate future renal replacement therapy (RRT) requirements, including dialysis.
The SCD has also gained FDA breakthrough device designation for several other indications, including chronic dialysis and hepatorenal syndrome.
AKI is a sudden and temporary loss of kidney function, often caused by conditions such as severe trauma, Covid-19, and sepsis.
In July 2022, SeaStar sought humanitarian device exemption (HDE) approval from the FDA to use its SCD to treat children with AKI.
