Selective Cytopheretic Device for Acute Kidney Injury
(NEUTRALIZE-AKI Trial)
Recruiting in Palo Alto (17 mi)
+44 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: SeaStar Medical
Disqualifiers: Advanced malignancy, COVID-19, ESRD, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the Selective Cytopheretic Device treatment for acute kidney injury?
Research shows that the Selective Cytopheretic Device (SCD) treatment can improve outcomes for patients with acute kidney injury (AKI) in the intensive care unit. In one study, patients treated with SCD had a significantly lower death rate compared to those who did not receive the treatment, and all surviving patients were able to stop dialysis by day 60.
12345How is the Selective Cytopheretic Device treatment different from other treatments for acute kidney injury?
The Selective Cytopheretic Device (SCD) is unique because it is a cell-directed extracorporeal therapy that specifically targets activated leukocytes (white blood cells) to reduce systemic inflammation, unlike traditional treatments that focus on filtering or adsorbing cytokines. This novel approach aims to improve outcomes in patients with acute kidney injury by addressing the underlying immune dysregulation.
12345Eligibility Criteria
This trial is for adults aged 18-80 in the ICU with severe Acute Kidney Injury (AKI) needing continuous kidney replacement therapy. They must have another life-threatening organ dysfunction, been on CKRT for 12-48 hours, and not expected to be moved to hospice or comfort care within 96 hours. Exclusions include pregnancy, prisoners, those with certain transplants or cancers under treatment, active COVID-19 as primary diagnosis, heavy bleeding at screening time, and a weight over 150kg.Inclusion Criteria
I have been on continuous kidney replacement therapy for 12 to 48 hours.
I am in the ICU and need continuous kidney replacement therapy.
Initial (non-binding) commitment to maintaining current level of care for at least 96 hours
+5 more
Exclusion Criteria
Patient is pregnant or breast feeding
I am currently hospitalized with COVID-19 as my main diagnosis.
Severe burns >45% total body surface area
+23 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive up to ten sequential 24-hour treatments with the Selective Cytopheretic Device (SCD) in addition to standard CKRT therapy
10 days
Daily treatments in ICU
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of mortality or dialysis dependency at 90 days
90 days
Long-term follow-up
Participants are assessed for dialysis dependence and other outcomes at one year
1 year
Participant Groups
The study tests if using the Selective Cytopheretic Device (SCD) alongside standard continuous kidney replacement therapy improves survival rates and reduces dialysis duration in AKI patients compared to standard therapy alone. About 200 participants will receive up to ten sequential treatments of SCD or just standard care across multiple US sites.
2Treatment groups
Experimental Treatment
Group I: SCD + CKRT ArmExperimental Treatment1 Intervention
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.
Group II: CKRT Alone Arm (standard of care)Experimental Treatment1 Intervention
This arm will receive standard of care CKRT therapy for their condition as appropriate.
Selective Cytopheretic Device is already approved in United States for the following indications:
🇺🇸 Approved in United States as QUELIMMUNE for:
- Acute kidney injury (AKI) due to sepsis or a septic condition on antibiotic therapy and requiring renal replacement therapy (RRT) in pediatric patients (weight ≥10kg and age ≤22 years)
- Chronic systemic inflammation in end-stage renal disease (ESRD) patients who require chronic hemodialysis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Doctor's Hospital of AugustaAugusta, GA
Virginia Commonwealth University HospitalRichmond, VA
University of Arkansas HospitalLittle Rock, AR
UCHealth University of Colorado HospitalAurora, CO
More Trial Locations
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Who Is Running the Clinical Trial?
SeaStar MedicalLead Sponsor
ICON plcIndustry Sponsor
References
Immunomodulatory therapy using a pediatric dialysis system ameliorates septic shock in miniature pigs. [2023]Application of the immunomodulatory selective cytopheretic device (SCD) to enhance renal replacement therapy and improve outcomes of acute kidney injury in pediatric patients is impeded by safety concerns. Therapy using a pediatric hemodialysis system could overcome these limitations.
Safety Summary of the Selective Cytopheretic Device: A Review of Safety Data Across Multiple Clinical Trials in ICU Patients With Acute Kidney Injury and Multiple Organ Failure. [2023]Acute kidney injury (AKI) requiring continuous kidney replacement therapy is a significant complication in ICU patients with mortality rates exceeding 50%. A dysregulated immune response can lead to systemic inflammation caused by hyperactivity of pro-inflammatory neutrophils and monocytes leading to tissue damage. The selective cytopheretic device (SCD) is an investigational medical device in a new class of cell-directed extracorporeal therapies distinct from cytokine adsorbers or filters, as it targets activated leukocytes. These leukocytes are the cellular sources driving this hyperinflammatory process. The objective of this report is to summarize the safety experience from clinical studies of the SCD in ICU patients with AKI or acute respiratory distress syndrome (ARDS) and multiple organ dysfunction (MOD).
A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients with Acute Kidney Injury. [2018]Acute kidney injury (AKI) is a highly morbid condition in critically ill patients that is associated with high mortality. Previous clinical studies have demonstrated the safety and efficacy of the Selective Cytopheretic Device (SCD) in the treatment of AKI requiring continuous renal replacement therapy in the intensive care unit (ICU).
The effect of the selective cytopheretic device on acute kidney injury outcomes in the intensive care unit: a multicenter pilot study. [2013]Acute kidney injury (AKI) is characterized by deterioration in kidney function resulting in multisystem abnormalities. Much of the morbidity and mortality associated with AKI result from a systemic inflammatory response syndrome (SIRS). This study described herein is a prospective, single-arm, multicenter US study designed to evaluate the safety and efficacy of the Selective Cytopheretic Device (SCD) treatment on AKI requiring continuous renal replacement therapy (CRRT) in the ICU. The study enrolled 35 subjects. The mean age was 56.3±15. With regard to race, 71.4% of the subjects were Caucasian, 22.9% were Black, and 5.7% were Hispanic. Average SOFA score was 11.3±3.6. Death from any cause at Day 60 was 31.4%. Renal recovery, defined as dialysis independence, was observed in all of the surviving subjects at Day 60. The results of this pilot study indicate the potential for a substantial improvement in patient outcomes over standard of care therapy, which is associated with a greater than 50% 60-day mortality in the literature. The SCD warrants further study in scientifically sound, pivotal trial to demonstrate reasonable assurance of safety and effectiveness.
The effects of a novel therapeutic device on acute kidney injury outcomes in the intensive care unit: a pilot study. [2015]Despite decades of improvements in the provision of renal replacement therapy, the morbidity and mortality associated with acute kidney injury (AKI) in the intensive care unit (ICU) setting remains extremely high. Much of the morbidity and mortality of this disorder is the consequence of systemic cellular damage that results from immune dysregulation. This is a prospective, single-arm, single-center study designed to evaluate the safety and efficacy of treatment with a selective cytopheretic device (SCD) on clinical outcomes in AKI requiring renal replacement therapy in the ICU. The patients enrolled in the trial were compared with historical case-matched controls with respect to age and Sequential Organ Failure Assessment (SOFA) score. The mortality for the case-matched controls was 77.78%, whereas the mortality in the SCD treatment group was 22.22% (p = 0.027). Multiple regression analysis identified treatment with SCD as the only significant variable affecting mortality among age, SOFA score, average change in urine output over the first 7 days during or after treatment. Mean total urine output in the 10 subjects receiving SCD treatment increased from a baseline of approximately 500 ml/d to more than 2,000 ml/d by day 7 of treatment. The SCD represents a novel therapeutic approach to alter the acute inflammatory response seen in AKI, and further evaluation of the safety and efficacy of the device is being evaluated in a multicenter investigation in the United States under an Food and Drug Administration (FDA) approved investigational device exemption (IDE).