Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - a Randomized Clinical Trial in Acute Kidney Injury (NEUTRALIZE-AKI)

SeaStar Medical

Status: Enrolling

Conditions: Acute Kidney Injury

Treatments: Device: Selective Cytopheretic Device; Other: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT05758077

SCD-006

Details and patient eligibility

About

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 200 subjects across 30 US sites. Participants will be patients in an intensive care unit (ICU) setting with a diagnosis of AKI requiring CKRT.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

SCD + CKRT Arm

Experimental group

Description:

In addition to standard of care CKRT therapy for these subjects, these subjects will have up to ten sequential 24-hour treatments with the Selective Cytopheretic Device (SCD) in-line with their existing CKRT circuit.

Treatment:

Device: Selective Cytopheretic Device

CKRT Alone Arm (standard of care)

Other group

Description:

This arm will receive standard of care CKRT therapy for their condition as appropriate.

Treatment:

Other: Standard of Care