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

NCT05758077 | Recruiting DMC FDA Device

• 1 other identifier: SCD-006
• Study Type: interventional
• Target: 339
• Locations: 1 country
• Sites: 38

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• MAKE90

  90 days

• Dialysis dependence

  1 year

• ICU free days in the first 28 days

  28 days

• Mortality at 28 days

  28 days

Study Arms (2)

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.

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.

Other: Standard of Care

Interventions

Selective Cytopheretic Device 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.

Also known as: SCD

SCD + CKRT Arm

Standard of Care OTHER

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

CKRT Alone Arm (standard of care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SeaStar Medical: lead

Study Sites (38)

University of Alabama Birmingham Hospital

Birmingham, Alabama, 35233, United States

RECRUITING

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

NOT YET RECRUITING

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

RECRUITING

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94143, United States

NOT YET RECRUITING

University of Colorado Hospital Anschutz Medical Campus

Aurora, Colorado, 80045, United States

WITHDRAWN

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

NOT YET RECRUITING

AdventHealth Orlando

Orlando, Florida, 32803, United States

NOT YET RECRUITING

Orlando Regional Medical Center

Orlando, Florida, 32806, United States

WITHDRAWN

Emory Healthcare

Atlanta, Georgia, 30322, United States

NOT YET RECRUITING

JMS Burn Center

Augusta, Georgia, 30909, United States

WITHDRAWN

Northeast Georgia Health System

Gainesville, Georgia, 30501, United States

NOT YET RECRUITING

University of Iowa Hospital

Iowa City, Iowa, 52242, United States

RECRUITING

University of Kentucky HealthCare

Lexington, Kentucky, 40536, United States

NOT YET RECRUITING

Ochsner LSU Health Academic Medical Center

Shreveport, Louisiana, 71103, United States

RECRUITING

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

NOT YET RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Henry Ford Medical Center

Detroit, Michigan, 48202, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55902, United States

RECRUITING

UNLV Health

Las Vegas, Nevada, 89154, United States

NOT YET RECRUITING

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

NOT YET RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45219, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

NOT YET RECRUITING

Samaritan Health

Corvallis, Oregon, 97330, United States

RECRUITING

St Luke's University Hospital

Bethlehem, Pennsylvania, 19015, United States

RECRUITING

Saint Mary Medical Center

Langhorne, Pennsylvania, 19047, United States

RECRUITING

Nazareth Hospital

Philadelphia, Pennsylvania, 19152, United States

NOT YET RECRUITING

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

NOT YET RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

NOT YET RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

RECRUITING

United States Army Institute of Surgical Research

JBSA Fort Sam Houston, Texas, 78234, United States

WITHDRAWN

Methodist Hospital Metropolitan

San Antonio, Texas, 78212, United States

RECRUITING

Methodist Hospital

San Antonio, Texas, 78229, United States

RECRUITING

University of Texas Health San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Sentara Health

Norfolk, Virginia, 23507, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

NOT YET RECRUITING

Related Publications (31)

• 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.

  PMID: 7333033 BACKGROUND

• Hall 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.

  PMID: 5506002 BACKGROUND

• VA/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.

  PMID: 18492867 BACKGROUND

• Palevsky 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.

  PMID: 19678919 BACKGROUND

• Van 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.

  PMID: 12637642 BACKGROUND

• Liano 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.

  PMID: 9580541 BACKGROUND

• Uchino 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.

  PMID: 16106006 BACKGROUND

• Metnitz 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.

  PMID: 12352040 BACKGROUND

• McCarthy 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.

  PMID: 8577185 BACKGROUND

• Star RA. Treatment of acute renal failure. Kidney Int. 1998 Dec;54(6):1817-31. doi: 10.1046/j.1523-1755.1998.00210.x.

  PMID: 9853246 BACKGROUND

• Simmons 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.

  PMID: 15086475 BACKGROUND

• Mutunga 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.

  PMID: 11208646 BACKGROUND

• Himmelfarb 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.

  PMID: 15339994 BACKGROUND

• Camon 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.

  PMID: 35347166 BACKGROUND

• Evans 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.

  PMID: 34605781 BACKGROUND

• Carson JL, Guyatt G, Heddle NM, Grossman BJ, Cohn CS, Fung MK, Gernsheimer T, Holcomb JB, Kaplan LJ, Katz LM, Peterson N, Ramsey G, Rao SV, Roback JD, Shander A, Tobian AA. Clinical Practice Guidelines From the AABB: Red Blood Cell Transfusion Thresholds and Storage. JAMA. 2016 Nov 15;316(19):2025-2035. doi: 10.1001/jama.2016.9185.

  PMID: 27732721 BACKGROUND

• Compher C, Bingham AL, McCall M, Patel J, Rice TW, Braunschweig C, McKeever L. Guidelines for the provision of nutrition support therapy in the adult critically ill patient: The American Society for Parenteral and Enteral Nutrition. JPEN J Parenter Enteral Nutr. 2022 Jan;46(1):12-41. doi: 10.1002/jpen.2267. Epub 2022 Jan 3.

  PMID: 34784064 BACKGROUND

• Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.

  PMID: 8844239 BACKGROUND

• Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.

  PMID: 22890468 BACKGROUND

• Nanchal R, Subramanian R, Karvellas CJ, Hollenberg SM, Peppard WJ, Singbartl K, Truwit J, Al-Khafaji AH, Killian AJ, Alquraini M, Alshammari K, Alshamsi F, Belley-Cote E, Cartin-Ceba R, Dionne JC, Galusca DM, Huang DT, Hyzy RC, Junek M, Kandiah P, Kumar G, Morgan RL, Morris PE, Olson JC, Sieracki R, Steadman R, Taylor B, Alhazzani W. Guidelines for the Management of Adult Acute and Acute-on-Chronic Liver Failure in the ICU: Cardiovascular, Endocrine, Hematologic, Pulmonary, and Renal Considerations. Crit Care Med. 2020 Mar;48(3):e173-e191. doi: 10.1097/CCM.0000000000004192.

  PMID: 32058387 BACKGROUND

• ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.

  PMID: 22797452 BACKGROUND

• Chung KK, Stewart IJ, Gisler C, Simmons JW, Aden JK, Tilley MA, Cotant CL, White CE, Wolf SE, Renz EM. The Acute Kidney Injury Network (AKIN) criteria applied in burns. J Burn Care Res. 2012 Jul-Aug;33(4):483-90. doi: 10.1097/BCR.0b013e31825aea8d.

  PMID: 22688091 BACKGROUND

• Yap E, Prysyazhnyuk Y, Ouyang J, Puri I, Boutin-Foster C, Salifu M. The Implication of Dropping Race from the MDRD Equation to Estimate GFR in an African American-Only Cohort. Int J Nephrol. 2021 Nov 16;2021:1880499. doi: 10.1155/2021/1880499. eCollection 2021.

  PMID: 34824870 BACKGROUND

• Self WH, Semler MW, Wanderer JP, Wang L, Byrne DW, Collins SP, Slovis CM, Lindsell CJ, Ehrenfeld JM, Siew ED, Shaw AD, Bernard GR, Rice TW; SALT-ED Investigators. Balanced Crystalloids versus Saline in Noncritically Ill Adults. N Engl J Med. 2018 Mar 1;378(9):819-828. doi: 10.1056/NEJMoa1711586. Epub 2018 Feb 27.

  PMID: 29485926 BACKGROUND

• Tumlin J, Wali R, Williams W, Murray P, Tolwani AJ, Vinnikova AK, Szerlip HM, Ye J, Paganini EP, Dworkin L, Finkel KW, Kraus MA, Humes HD. Efficacy and safety of renal tubule cell therapy for acute renal failure. J Am Soc Nephrol. 2008 May;19(5):1034-40. doi: 10.1681/ASN.2007080895. Epub 2008 Feb 13.

  PMID: 18272842 BACKGROUND

• Ding F, Yevzlin AS, Xu ZY, Zhou Y, Xie QH, Liu JF, Zheng Y, DaSilva JR, Humes HD. The effects of a novel therapeutic device on acute kidney injury outcomes in the intensive care unit: a pilot study. ASAIO J. 2011 Sep-Oct;57(5):426-32. doi: 10.1097/MAT.0b013e31820a1494.

  PMID: 21317636 BACKGROUND

• Tumlin JA, Galphin CM, Tolwani AJ, Chan MR, Vijayan A, Finkel K, Szamosfalvi B, Dev D, DaSilva JR, Astor BC, Yevzlin AS, Humes HD; SCD Investigator Group. A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients with Acute Kidney Injury. PLoS One. 2015 Aug 5;10(8):e0132482. doi: 10.1371/journal.pone.0132482. eCollection 2015.

  PMID: 26244978 BACKGROUND

• Tumlin JA, Chawla L, Tolwani AJ, Mehta R, Dillon J, Finkel KW, DaSilva JR, Astor BC, Yevzlin AS, Humes HD. The effect of the selective cytopheretic device on acute kidney injury outcomes in the intensive care unit: a multicenter pilot study. Semin Dial. 2013 Sep-Oct;26(5):616-23. doi: 10.1111/sdi.12032. Epub 2012 Oct 29.

  PMID: 23106607 BACKGROUND

• Goldstein SL, Askenazi DJ, Basu RK, Selewski DT, Paden ML, Krallman KA, Kirby CL, Mottes TA, Terrell T, Humes HD. Use of the Selective Cytopheretic Device in Critically Ill Children. Kidney Int Rep. 2020 Dec 19;6(3):775-784. doi: 10.1016/j.ekir.2020.12.010. eCollection 2021 Mar.

  PMID: 33732992 BACKGROUND

• Yessayan LT, Neyra JA, Westover AJ, Szamosfalvi B, Humes HD. Extracorporeal Immunomodulation Treatment and Clinical Outcomes in ICU COVID-19 Patients. Crit Care Explor. 2022 May 19;4(5):e0694. doi: 10.1097/CCE.0000000000000694. eCollection 2022 May.

  PMID: 35620768 BACKGROUND

• Yessayan L, Szamosfalvi B, Napolitano L, Singer B, Kurabayashi K, Song Y, Westover A, Humes HD. Treatment of Cytokine Storm in COVID-19 Patients With Immunomodulatory Therapy. ASAIO J. 2020 Nov/Dec;66(10):1079-1083. doi: 10.1097/MAT.0000000000001239.

  PMID: 33136592 BACKGROUND

Related Links

• CKD stages
• ICU Liberation Bundle

MeSH Terms

Conditions

Acute Kidney Injury; Inflammation; Kidney Cortex Necrosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Mohamed Zidan, MD

CONTACT

844-427-8100; mzidan@seastarmed.com

Kevin K Chung, MD

CONTACT

844-427-8100; kchung@seastarmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 7, 2023
• Study Start: April 17, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (38)