Recruiting

SeLective CytopheretIc Device

Sponsor:

SeaStar Medical

Code:

NCT05758077

Conditions

Acute Kidney Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Selective Cytopheretic Device

Standard of Care

Study Details

Brief summary:

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.

Conditions

Acute Kidney Injury

Study ID

NCT05758077

Start date

Apr 17, 2023

Status verified date

Jan, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

339 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SCD + CKRT Arm

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.

other: CKRT Alone Arm (standard of care)

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

Interventions

Selective Cytopheretic Device

The Selective Cytopheretic Device (SCD) is comprised of tubing, connectors, and a synthetic hollow fiber membrane cartridge. The device is connected in series to a commercially available CKRT hemofilter. Blood from the CKRT circuit is diverted after the CKRT hemofilter through to the extracapillary space (ECS) of the SCD cartridge. Blood circulates through the SCD ECS and then it is returned to the patient via the venous return line of the CKRT circuit. Regional citrate anticoagulation is used for the entire CKRT and SCD blood circuit.

The SCD cartridge incorporates a synthetic hollow fiber membrane with the ability to bind activated leukocytes to its extracapillary surface; and when used in a CKRT extracorporeal circuit in the presence of regional citrate anticoagulation, the SCD modulates inflammation.

Standard of Care

Standard of care CKRT for the subject's condition, as appropriate

Primary outcome measure

  • Composite endpoint of mortality or dialysis dependency at 90 days [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Mohamed Zidan, MD

844-427-8100mzidan@seastarmed.com

Kevin K Chung, MD

844-427-8100kchung@seastarmed.com

Locations

University of Alabama Birmingham Hospital

Recruiting

Birmingham, Alabama, United States, 35233

Ronald Reagan UCLA Medical Center

Recruiting

Los Angeles, California, United States, 90095

Stanford University

Recruiting

Palo Alto, California, United States, 94304

University of Iowa Hospital

Recruiting

Iowa City, Iowa, United States, 52242

Ochsner LSU Health Academic Medical Center

Recruiting

Shreveport, Louisiana, United States, 71103

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Henry Ford Medical Center

Recruiting

Detroit, Michigan, United States, 48202

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55902

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45219

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Samaritan Health

Recruiting

Corvallis, Oregon, United States, 97330

St Luke's University Hospital

Recruiting

Bethlehem, Pennsylvania, United States, 19015

Saint Mary Medical Center

Recruiting

Langhorne, Pennsylvania, United States, 19047

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Brooke Army Medical Center

Recruiting

Fort Sam Houston, Texas, United States, 78234

Methodist Hospital Metropolitan

Recruiting

San Antonio, Texas, United States, 78212

Methodist Hospital

Recruiting

San Antonio, Texas, United States, 78229

University of Texas Health San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Sentara Health

Recruiting

Norfolk, Virginia, United States, 23507

More Information

Sponsor

SeaStar Medical

Last update posted

Apr 23, 2026

Last verified

Jan, 2026

Keywords

  • continuous kidney replacement therapy
  • continuous renal replacement therapy
  • acute kidney injury
  • organ failure
  • inflammation
  • dialysis
  • acute tubular necrosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by SeaStar Medical on 2026-04-23.