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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Alabama Birmingham Hospital
  Birmingham, Alabama, United States Recruiting
• Ronald Reagan UCLA Medical Center
  Los Angeles, California, United States Recruiting
• Stanford University
  Palo Alto, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• AdventHealth Orlando
  Orlando, Florida, United States Recruiting
• Emory Healthcare
  Atlanta, Georgia, United States Recruiting

Study contacts

• Study coordinator: Mohamed Zidan, MD
• Email: mzidan@seastarmed.com
• Phone: 844-427-8100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.