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Using a device to deactivate immune cells in patients with acute kidney injury

A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients With Acute Kidney Injury Requiring Continuous Kidney Replacement Therapy

NA · SeaStar Medical · NCT05758077

This study is testing if a new device can help improve survival for patients with severe kidney injury who need ongoing kidney treatment.

Quick facts

PhaseNA
Study typeInterventional
Enrollment339 (estimated)
Ages18 Years and up
SexAll
SponsorSeaStar Medical (industry)
Drugs / interventionschemotherapy, radiation, prednisone
Locations38 sites (Birmingham, Alabama and 37 other locations)
Trial IDNCT05758077 on ClinicalTrials.gov

What this trial studies

This randomized, controlled clinical trial aims to evaluate the effectiveness of the Selective Cytopheretic Device (SCD) in improving survival rates for patients with Acute Kidney Injury (AKI) who require continuous kidney replacement therapy (CKRT). Participants will receive up to ten sequential 24-hour treatments with the SCD, compared to standard CKRT alone. The study will enroll approximately 200 patients across 30 sites in the U.S., specifically targeting those in intensive care units with severe AKI. The primary goal is to determine if SCD therapy can enhance survival and reduce the need for prolonged dialysis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with stage 2 or greater AKI requiring CKRT and at least one additional life-threatening organ dysfunction.

Not a fit: Patients who are not expected to survive the next 24 hours or those transitioning to comfort measures will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and reduce the duration of dialysis for patients with acute kidney injury.

How similar studies have performed: While this approach is novel, similar studies targeting immune modulation in critical care settings have shown promise, suggesting potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Admitted to an ICU requiring CKRT:

  1. Must have AKI stage 2 or greater at the time of CKRT initiation.
  2. Must have been on CKRT for at least 12 hours but no greater than 48 hours at the time of enrollment.
* At least 18 years of age but not older than 80 at the time of enrollment.
* One additional life-threatening organ dysfunction present.
* Acceptable vascular access for CKRT to include adequate lumen size and length of catheters.
* Initial (non-binding) commitment to maintaining current level of care for at least 96 hours.
* C-Reactive Protein \>3.5 mg/dl.

Exclusion Criteria:

* Not expected to survive next 24 hours.
* Anticipated transition to comfort measures or hospice in next 4 days.
* Terminal condition whereby the patient is not expected to survive 28 days or any condition in which therapy is regarded as futile by the PI.
* Advanced malignancy which is actively being treated or may be treated with palliative chemotherapy or radiation.
* ICU hospitalization \> 14 days during this hospital admission (to include days spent at ICU of an outside hospital) at the time of screening.
* Active COVID-19 infection with a primary admission diagnosis of COVID-19.
* Chronic use of ventricular assist devices.
* ESRD requiring chronic kidney replacement therapy.
* History of CKD (greater than Stage 3).
* AKI stage 0 or stage 1 at the time of CKRT initiation.
* Non-ATN AKI diagnosis. We intend on relying on local nephrology subspecialty expertise to reasonably exclude non-ATN diagnoses based on clinical suspicions combined with prespecified objective criteria. If there is a reasonable suspicion that the subject has non-ATN AKI based on this, they will be excluded from the trial.
* Acute coronary syndromes, acute stroke, or acute major vascular compromise requiring medical or surgical interventions within 48 hours of randomization.
* Active hemorrhage requiring blood transfusions at the time of screening.
* Acute on Chronic Liver Failure.
* Suspicion of hepato-renal syndrome.
* Presence of any solid organ transplant at any time prior to admission.
* Severe burns with a modified Baux score \> 100 (%TBSA+Age+17 for Inhalation Injury).
* Bone marrow transplant within the last year.
* Chronic immunosuppression with an average of \>20 mg/day of prednisone or other steroid sparing immunosuppressants for the past 30 days prior to hospital admission.
* Individuals who have a history of primary or secondary immune disorders including, but not limited to, HIV or AIDS.
* Dry weight of \>150kg.
* Platelet count \<15,000/mm3.
* Patient is a prisoner or member of a vulnerable population.
* Patient is pregnant or breast feeding.
* Concurrent enrollment in another interventional clinical trial for an investigational drug or device.
* Need for plasmapheresis.

Where this trial is running

Birmingham, Alabama and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Acute Kidney Injury, continuous kidney replacement therapy, continuous renal replacement therapy, acute kidney injury, organ failure, inflammation, dialysis, acute tubular necrosis

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.