Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury

Recruiting now · Not applicable

Conditions studied: Acute Kidney Injury

In brief

This randomized, controlled, pivotal study is intended to determine whether up to ten sequential 24-hour treatments with the Selective Cytopheretic Device (SCD) will improve survival in patients with Acute Kidney Injury (AKI) requiring continuous kidney replacement therapy (CKRT) when compared to CKRT alone (standard of care). This study is further intended to determine whether SCD therapy will reduce the duration of maintenance dialysis secondary to AKI. This study will enroll approximately 339 subjects across 30 US sites. Participants will be patients in an intensive care unit (ICU) setting with a diagnosis of AKI requiring CKRT.

Key facts

Study ID

NCT05758077

Run by

SeaStar Medical

People needed

339

Starts

2023-04-17

Expected to finish

2027-06-01

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Admitted to an ICU requiring CKRT:
• Must have AKI stage 2 or greater at the time of CKRT initiation.
• 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.

You may not qualify if…

• 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.

Where it is running

• University of Iowa Hospital — Iowa City, Iowa, United States (enrolling)
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States (enrolling)
• University of Cincinnati — Cincinnati, Ohio, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Ochsner LSU Health Academic Medical Center — Shreveport, Louisiana, United States (enrolling)
• Samaritan Health — Corvallis, Oregon, United States (enrolling)
• St Luke's University Hospital — Bethlehem, Pennsylvania, United States (enrolling)
• Saint Mary Medical Center — Langhorne, Pennsylvania, United States (enrolling)
• Stanford University — Palo Alto, California, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Henry Ford Medical Center — Detroit, Michigan, United States (enrolling)
• University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• Brooke Army Medical Center — Fort Sam Houston, Texas, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Methodist Hospital Metropolitan — San Antonio, Texas, United States (enrolling)
• Methodist Hospital — San Antonio, Texas, United States (enrolling)
• University of Texas Health San Antonio — San Antonio, Texas, United States (enrolling)
• Sentara Health — Norfolk, Virginia, United States (enrolling)
• University of Alabama Birmingham Hospital — Birmingham, Alabama, United States (enrolling)
• Virginia Commonwealth University — Richmond, Virginia, United States
• Mayo Clinic in Arizona — Phoenix, Arizona, United States
• University of California San Francisco — San Francisco, California, United States
• University of Colorado Hospital Anschutz Medical Campus — Aurora, Colorado, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• AdventHealth Orlando — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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