SeaStar's NEUTRALIZE-AKI trial grows to 339 patients, pushes readout to 2026
SeaStar Medical raised its pivotal AKI trial's enrollment target 70% and pushed the completion date a year, testing whether its cytopheretic device beats CRRT alone on a 90-day mortality composite.
Executive Summary
- SeaStar Medical's pivotal device trial in acute kidney injury is still enrolling toward a company-guided 2026 readout, with a substantially larger patient pool than originally planned.
- The sponsor increased the trial's enrollment target and pushed back its completion timeline twice, extending the path to the mortality and dialysis-dependency readout rather than shrinking it.
- With no approved device or drug shown to alter outcomes in this setting, a result that separates from standard dialysis care on the composite endpoint would be the finding that matters.
- The device's mechanism has no direct competitor in active testing; the nearest peers are early-phase cell-therapy programs, leaving this readout without a resolved precedent to benchmark against.
The trial
NEUTRALIZE-AKI (NCT05758077) is a randomized, registrational trial testing SeaStar Medical's Selective Cytopheretic Device against continuous renal replacement therapy (CRRT, a form of continuous dialysis) alone in adults with acute kidney injury who are in intensive care with at least one additional life-threatening organ dysfunction. The primary endpoint is a composite of mortality or dialysis dependency at 90 days. Secondary endpoints include dialysis dependence, ICU-free days in the first 28 days, 90-day major adverse kidney events (MAKE90), and mortality at 28 days. The trial has recruited since April 2023 across 38 US sites and remains in Recruiting status. NCT05758077Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney InjuryNCT05758077
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
The enrollment change
The registry enrollment target rose from 200 to 339 patients, a 70% increase recorded on the trial record as of March 2026. Because this is a randomized, controlled pivotal design rather than an early-phase dose-finding study, an enrollment increase of this size extends the trial's timeline and its statistical power rather than signaling an operational problem. SeaStar's chief executive, Eric Schlorff, said in May 2025 that the trial had reached 50% enrollment, triggering a prespecified per-protocol interim analysis by the study's independent Data Safety Monitoring Review Board, with findings expected back to the company in the third quarter of 2025. NCT05758077+1Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney InjuryNCT05758077SeaStar Medical Reports First Quarter 2025 Financial Results and Provides Business UpdatesMay 14, 2025
The timing shift
The trial's primary completion date has moved twice: from November 2024 to December 2025 in October 2024, then from December 2025 to December 2026 in October 2025. That is a cumulative 25-month slip from the original guidance. Schlorff said in the same disclosure that the company looks "forward to completing the trial and potentially filing the Premarket Approval (PMA) application in 2026" and that management is "excited to unveil results from this trial in 2026," tying the readout to the same year the device's pediatric counterpart, QUELIMMUNE, is already commercial. NCT05758077+1Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney InjuryNCT05758077SeaStar Medical Reports First Quarter 2025 Financial Results and Provides Business UpdatesMay 14, 2025
The competitive field
No trial in the acute kidney injury field shares the device's neutrophil- and monocyte-deactivation mechanism; the nearest matches are early-phase cell-therapy programs, including a Phase 1/2 mesenchymal stem cell study and a Phase 1/2 autologous leukocyte study, both of which use a different cell-based approach and are not eligible as direct comparators. Beyond cell therapy, the wider AKI field includes late-stage attempts with distinct mechanisms, such as a citrate anticoagulation Phase 3 study and a TP53-targeted RNA therapy (teprasiran) in Phase 3, none of which shares this device's approach. With no approved device or drug shown to alter mortality or dialysis dependency in this population, a result that separates from CRRT alone on the composite endpoint, and holds up on the MAKE90 secondary measure, would be the finding that distinguishes this readout from the rest of the field.
Regulatory context
The FDA has granted the Selective Cytopheretic Device Breakthrough Device Designation for adult acute kidney injury use, most recently reaffirmed in May 2024, and separately approved the investigational device exemption for the pivotal 200-patient study design in February 2023, before the enrollment target was later raised. SeaStar has said it intends to file a premarket approval application following topline results, tying the regulatory submission directly to this trial's outcome. SeaStarSeaStar Medical Reports First Quarter 2025 Financial Results and Provides Business UpdatesMay 14, 2025
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.