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

Acute Kidney Injury Clinical Trial

— NEUTRALIZE-AKI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05758077
• Other study ID #: SCD-006
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: November 2025

Study information

• Verified date: June 2024
• Source: SeaStar Medical
• Contact: Mohamed Zidan, MD
• Phone: 844-427-8100
• Email: mzidan[@]seastarmed.com
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	JMS Burn Center	Augusta	Georgia
United States	University of Colorado Hospital Anschutz Medical Campus	Aurora	Colorado
United States	University of Alabama Birmingham Hospital	Birmingham	Alabama
United States	University of Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Samaritan Health	Corvallis	Oregon
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Henry Ford Medical Center	Detroit	Michigan
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	United States Army Institute of Surgical Research	Fort Sam Houston	Texas
United States	University of Iowa Hospital	Iowa City	Iowa
United States	Saint Mary Medical Center	Langhorne	Pennsylvania
United States	University of Kentucky HealthCare	Lexington	Kentucky
United States	Central Arkansas Veterans Healthcare	Little Rock	Arkansas
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	Sentara Health	Norfolk	Virginia
United States	Orlando Regional Medical Center	Orlando	Florida
United States	Stanford University	Palo Alto	California
United States	Nazareth Hospital	Philadelphia	Pennsylvania
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Methodist Hospital	San Antonio	Texas
United States	University of Texas Health San Antonio	San Antonio	Texas
United States	Ochsner LSU Health Academic Medical Center	Shreveport	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
SeaStar Medical	ICON plc

Country where clinical trial is conducted

United States, 

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint of mortality or dialysis dependency at 90 days	The composite of death or requiring kidney replacement therapy at 90 days post randomization	90 days
Secondary	MAKE90	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
Secondary	Dialysis dependence	Need for any form of kidney replacement therapy at one year	1 year
Secondary	ICU free days in the first 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
Secondary	Mortality at 28 days	Death by day 28 post randomization	28 days

External Links

•   CKD stages
•   ICU Liberation Bundle