Acute Kidney InjuryNEUTRALIZE-AKINCT05758077
Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury
A study testing Selective Cytopheretic Device in people with Acute Kidney Injury, run by SeaStar Medical at 36 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Selective Cytopheretic Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 36 sitesUnited States
- Study dates
- 17 Apr 2023to Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to an ICU requiring CKRT:
- Must have AKI stage 2 or greater at the time of CKRT initiation.
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
36 sites in 1 country. Contact the study team or a site near you to ask about taking part.
36 sites in 1 country
United States36 sites, 32 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
- Recruiting
Emory Healthcare
Atlanta, Georgia, 30322
- Withdrawn
JMS Burn Center
Augusta, Georgia, 30909
- Withdrawn
University of Colorado Hospital Anschutz Medical Campus
Aurora, Colorado, 80045
- Recruiting
University of Maryland Medical Center
Baltimore, Maryland, 21201
- Recruiting
St Luke's University Hospital
Bethlehem, Pennsylvania, 19015
- Recruiting
University of Alabama Birmingham Hospital
Birmingham, Alabama, 35233
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27599
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45219
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
- Not yet recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
- Active, not recruiting
Samaritan Health
Corvallis, Oregon, 97330
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
- Recruiting
Henry Ford Medical Center
Detroit, Michigan, 48202
- Recruiting
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
- Not yet recruiting
Northeast Georgia Health System
Gainesville, Georgia, 30501
- Recruiting
University of Iowa Hospital
Iowa City, Iowa, 52242
- Not yet recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
- Withdrawn
United States Army Institute of Surgical Research
JBSA Fort Sam Houston, Texas, 78234
- Recruiting
Saint Mary Medical Center
Langhorne, Pennsylvania, 19047
- Not yet recruiting
University of Kentucky HealthCare
Lexington, Kentucky, 40536
- Not yet recruiting
Keck Hospital of USC
Los Angeles, California, 90033
- Recruiting
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
- Not yet recruiting
The Mount Sinai Hospital
New York, New York, 10029
- Recruiting
Sentara Health
Norfolk, Virginia, 23507
- Recruiting
AdventHealth Orlando
Orlando, Florida, 32803
- Recruiting
Stanford University
Palo Alto, California, 94304
- Not yet recruiting
Mayo Clinic in Arizona
Phoenix, Arizona, 85054
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55902
- Recruiting
Methodist Hospital Metropolitan
San Antonio, Texas, 78212
- Recruiting
Methodist Hospital
San Antonio, Texas, 78229
- Recruiting
University of Texas Health San Antonio
San Antonio, Texas, 78229
- Recruiting
University of California San Francisco
San Francisco, California, 94143
- Recruiting
Ochsner LSU Health Academic Medical Center
Shreveport, Louisiana, 71103
- Not yet recruiting
Stony Brook University Hospital
Stony Brook, New York, 11794
About this study
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
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
- Being tested
- Selective Cytopheretic Device, Standard of Care
- Keywords
- continuous kidney replacement therapy, continuous renal replacement therapy, acute kidney injury, organ failure, inflammation, dialysis, acute tubular necrosis
- Medical subject headings
- Acute Kidney Injury, Inflammation, Kidney Cortex Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Cytopheretic DeviceDevice
Also called SCD
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 CareOther
Standard of care CKRT for the subject's condition, as appropriate
| Study group | Role | What they receive |
|---|---|---|
| SCD + CKRT Arm | Experimental | 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. Receives: Device: Selective Cytopheretic Device |
| CKRT Alone Arm (standard of care) | Other | This arm will receive standard of care CKRT therapy for their condition as appropriate. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of mortality or dialysis dependency at 90 days
The composite of death or requiring kidney replacement therapy at 90 days post randomization
Measured: 90 days
Secondary outcomes (4)
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
Measured: 90 days
Dialysis dependence
Need for any form of kidney replacement therapy at one year
Measured: 1 year
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
Measured: 28 days
Mortality at 28 days
Death by day 28 post randomization
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start17 Apr 2023
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 339 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SeaStar Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758077
- Sponsor's protocol ID
- SCD-006
- Acronym
- NEUTRALIZE-AKI
- Status last verified
- Jan 2026
- First submitted
- 24 Feb 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kjellstrand CM, Gornick C, Davin T. Recovery from acute renal failure. Clin Exp Dial Apheresis. 1981;5(1-2):143-61. doi: 10.3109/08860228109076011.
PubMed 7333033Hall JW, Johnson WJ, Maher FT, Hunt JC. Immediate and long-term prognosis in acute renal failure. Ann Intern Med. 1970 Oct;73(4):515-21. doi: 10.7326/0003-4819-73-4-515. No abstract available.
PubMed 5506002VA/NIH Acute Renal Failure Trial Network; Palevsky PM, Zhang JH, O'Connor TZ, Chertow GM, Crowley ST, Choudhury D, Finkel K, Kellum JA, Paganini E, Schein RM, Smith MW, Swanson KM, Thompson BT, Vijayan A, Watnick S, Star RA, Peduzzi P. Intensity of renal support in critically ill patients with acute kidney injury. N Engl J Med. 2008 Jul 3;359(1):7-20. doi: 10.1056/NEJMoa0802639. Epub 2008 May 20.
PubMed 18492867Palevsky PM, O'Connor TZ, Chertow GM, Crowley ST, Zhang JH, Kellum JA; US Department of Veterans Affairs/National Institutes of Health Acute Renal Failure Trial Network. Intensity of renal replacement therapy in acute kidney injury: perspective from within the Acute Renal Failure Trial Network Study. Crit Care. 2009;13(4):310. doi: 10.1186/cc7901. Epub 2009 Aug 11.
PubMed 19678919Van Den Noortgate N, Mouton V, Lamot C, Van Nooten G, Dhondt A, Vanholder R, Afschrift M, Lameire N. Outcome in a post-cardiac surgery population with acute renal failure requiring dialysis: does age make a difference? Nephrol Dial Transplant. 2003 Apr;18(4):732-6. doi: 10.1093/ndt/gfg043.
PubMed 12637642Liano F, Junco E, Pascual J, Madero R, Verde E. The spectrum of acute renal failure in the intensive care unit compared with that seen in other settings. The Madrid Acute Renal Failure Study Group. Kidney Int Suppl. 1998 May;66:S16-24.
PubMed 9580541Uchino S, Kellum JA, Bellomo R, Doig GS, Morimatsu H, Morgera S, Schetz M, Tan I, Bouman C, Macedo E, Gibney N, Tolwani A, Ronco C; Beginning and Ending Supportive Therapy for the Kidney (BEST Kidney) Investigators. Acute renal failure in critically ill patients: a multinational, multicenter study. JAMA. 2005 Aug 17;294(7):813-8. doi: 10.1001/jama.294.7.813.
PubMed 16106006Metnitz PG, Krenn CG, Steltzer H, Lang T, Ploder J, Lenz K, Le Gall JR, Druml W. Effect of acute renal failure requiring renal replacement therapy on outcome in critically ill patients. Crit Care Med. 2002 Sep;30(9):2051-8. doi: 10.1097/00003246-200209000-00016.
PubMed 12352040McCarthy JT. Prognosis of patients with acute renal failure in the intensive-care unit: a tale of two eras. Mayo Clin Proc. 1996 Feb;71(2):117-26. doi: 10.4065/71.2.117.
PubMed 8577185Star RA. Treatment of acute renal failure. Kidney Int. 1998 Dec;54(6):1817-31. doi: 10.1046/j.1523-1755.1998.00210.x.
PubMed 9853246Simmons EM, Himmelfarb J, Sezer MT, Chertow GM, Mehta RL, Paganini EP, Soroko S, Freedman S, Becker K, Spratt D, Shyr Y, Ikizler TA; PICARD Study Group. Plasma cytokine levels predict mortality in patients with acute renal failure. Kidney Int. 2004 Apr;65(4):1357-65. doi: 10.1111/j.1523-1755.2004.00512.x.
PubMed 15086475Mutunga M, Fulton B, Bullock R, Batchelor A, Gascoigne A, Gillespie JI, Baudouin SV. Circulating endothelial cells in patients with septic shock. Am J Respir Crit Care Med. 2001 Jan;163(1):195-200. doi: 10.1164/ajrccm.163.1.9912036.
PubMed 11208646Himmelfarb J, McMonagle E, Freedman S, Klenzak J, McMenamin E, Le P, Pupim LB, Ikizler TA, The PICARD Group. Oxidative stress is increased in critically ill patients with acute renal failure. J Am Soc Nephrol. 2004 Sep;15(9):2449-56. doi: 10.1097/01.ASN.0000138232.68452.3B.
PubMed 15339994Camon AM, Alonso R, Munoz FJ, Cardozo C, Bernal-Maurandi J, Albiach L, Aguero D, Marcos MA, Ambrosioni J, Bodro M, Chumbita M, De la Mora L, Garcia-Pouton N, Duenas G, Hernandez-Meneses M, Inciarte A, Cuesta G, Meira F, Morata L, Puerta-Alcalde P, Rico V, Herrera S, Tuset M, Castro P, Prieto-Gonzalez S, Almuedo A, Munoz J, Mensa J, Sanjuan G, Nicolas JM, Del Rio A, Vila J, Garcia F, Martinez JA, Garcia-Vidal C, Soriano A; Hospital Clinic of Barcelona COVID-19 Research Group. C-reactive protein cut-off for early tocilizumab and dexamethasone prescription in hospitalized patients with COVID-19. Sci Rep. 2022 Mar 28;12(1):5250. doi: 10.1038/s41598-022-08882-x.
PubMed 35347166Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Hylander Moller M, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. Crit Care Med. 2021 Nov 1;49(11):e1063-e1143. doi: 10.1097/CCM.0000000000005337. No abstract available.
PubMed 34605781