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

February 1, 2024 updated by: SeaStar Medical

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Not yet recruiting
        • University of Alabama Birmingham Hospital
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Not yet recruiting
        • Central Arkansas Veterans Healthcare
    • California
      • Palo Alto, California, United States, 94304
        • Not yet recruiting
        • Stanford University
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • University of Colorado Hospital Anschutz Medical Campus
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Recruiting
        • JMS Burn Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Not yet recruiting
        • University of Iowa Hospital
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Not yet recruiting
        • University of Kentucky HealthCare
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Not yet recruiting
        • Ochsner LSU Health Academic Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Not yet recruiting
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • Cleveland Clinic
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Recruiting
        • Samaritan Health
    • Texas
      • Dallas, Texas, United States, 75390
        • Not yet recruiting
        • University of Texas Southwestern Medical Center
      • Fort Sam Houston, Texas, United States, 78234
        • Not yet recruiting
        • Brooke Army Medical Center
      • Fort Sam Houston, Texas, United States, 78234
        • Not yet recruiting
        • United States Army Institute of Surgical Research
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Methodist Hospital
      • San Antonio, Texas, United States, 78229
        • Not yet recruiting
        • University of Texas Health San Antonio
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Not yet recruiting
        • Sentara Health
      • Richmond, Virginia, United States, 23219
        • Not yet recruiting
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.
  • Acute or 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 >45% total body surface area.
  • Bone marrow transplant within the last year.
  • Chronic immunosuppression.
  • 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.
  • Requiring plasmapheresis for any reason during the hospitalization.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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.

Other Names:
  • SCD
Other: CKRT Alone Arm (standard of care)
This arm will receive standard of care CKRT therapy for their condition as appropriate.
Other: Standard of Care
Standard of care CKRT for the subject's condition, as appropriate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite endpoint of mortality or dialysis dependency at 90 days
Time Frame: 90 days
The composite of death or requiring kidney replacement therapy at 90 days post randomization
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MAKE90
Time Frame: 90 days
Major adverse kidney events at day 90 is a composite of death, need for KRT, or persistent renal dysfunction (final serum creatinine concentration, ≥200% of the baseline value) at the 90 day follow up period
90 days
Dialysis dependence
Time Frame: 1 year
Need for any form of kidney replacement therapy at one year
1 year
ICU free days in the first 28 days
Time Frame: 28 days
The number of days alive and requiring ICU level of care in the 28 days after randomization for at least 24 hours
28 days
Mortality at 28 days
Time Frame: 28 days
Death by day 28 post randomization
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SeaStar Medical

Collaborators

ICON plc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

February 24, 2023

First Submitted That Met QC Criteria

February 24, 2023

First Posted (Actual)

March 7, 2023

Study Record Updates

Last Update Posted (Actual)

February 2, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCD-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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