Selective Cytopheretic Device for Acute Kidney Injury

(NEUTRALIZE-AKI Trial)

Recruiting at 42 trial locations

Overseen By Kevin K Chung, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SeaStar Medical

Disqualifiers: Advanced malignancy, COVID-19, ESRD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 10 days

200 Participants Needed

What You Need to Know Before You Apply

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.

How 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. ^{1 2 3 4 5}

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. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Selective Cytopheretic Device

Trial Overview 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.

How Is the Trial Designed?

Group I: SCD + CKRT Arm Experimental Treatment 1 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 Treatment 1 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

Who Is Running the Clinical Trial?

SeaStar Medical

Lead Sponsor

Trials

6

Recruited

690+

ICON plc

Industry Sponsor

Trials

88

Recruited

28,900+

Dr. Steve Cutler

ICON plc

Chief Executive Officer since 2017

PhD from the University of Sydney, MBA from the University of Birmingham

Dr. Greg Licholai

ICON plc

Chief Medical Officer since 2023

Degrees from Harvard Business School, Yale School of Medicine, Columbia University, and Boston College

Published Research Related to This Trial

The immunomodulatory selective cytopheretic device (SCD) was safely integrated into the CARPEDIEM™ pediatric hemodialysis system, allowing for 6 hours of treatment without affecting pump operation, which is crucial for pediatric patients with acute kidney injury.

SCD therapy improved outcomes in septic minipigs by maintaining higher blood pressure and reducing lactic acidosis compared to standard hemodiafiltration, suggesting it may effectively reduce organ dysfunction in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunomodulatory therapy using a pediatric dialysis system ameliorates septic shock in miniature pigs. Johnston, KA., Pino, CJ., Chan, G., et al.[2023]

The selective cytopheretic device (SCD) has been tested in 151 ICU patients with acute kidney injury (AKI) or acute respiratory distress syndrome (ARDS), showing no device-related infections or serious adverse events across over 800 treatment sessions.

The SCD appears to be a safe and effective extracorporeal therapy that targets activated leukocytes, potentially reducing hyperinflammation in critically ill patients without increasing safety risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Humes, HD., Goldstein, SL., Yessayan, LT., et al.[2023]

In a randomized trial of 134 ICU patients with acute kidney injury, the Selective Cytopheretic Device (SCD) therapy showed a potential reduction in 60-day mortality and dialysis dependency compared to standard continuous renal replacement therapy (CRRT), particularly in patients who maintained recommended ionized calcium levels during treatment.

While there was no significant difference in overall 60-day mortality between the SCD and control groups, patients receiving SCD therapy had a much lower combined rate of mortality and dialysis dependency (16% vs. 58%), suggesting that SCD may offer benefits in specific patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients with Acute Kidney Injury. Tumlin, JA., Galphin, CM., Tolwani, AJ., et al.[2018]

In a pilot study involving 35 ICU patients with acute kidney injury (AKI), the Selective Cytopheretic Device (SCD) treatment showed promising results, with all surviving patients achieving renal recovery (dialysis independence) by Day 60.

The study indicated a 31.4% mortality rate at Day 60, which is significantly lower than the over 50% mortality rate typically associated with standard care for AKI, suggesting that SCD may improve patient outcomes and warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of the selective cytopheretic device on acute kidney injury outcomes in the intensive care unit: a multicenter pilot study. Tumlin, JA., Chawla, L., Tolwani, AJ., et al.[2013]

In a study of 10 ICU patients with acute kidney injury (AKI) requiring renal replacement therapy, treatment with a selective cytopheretic device (SCD) significantly reduced mortality from 77.78% in historical controls to 22.22% (p = 0.027).

The SCD treatment also led to a substantial increase in urine output, rising from about 500 ml/d to over 2,000 ml/d by day 7, indicating its potential efficacy in improving kidney function during AKI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a novel therapeutic device on acute kidney injury outcomes in the intensive care unit: a pilot study. Ding, F., Yevzlin, AS., Xu, ZY., et al.[2015]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Immunomodulatory therapy using a pediatric dialysis system ameliorates septic shock in miniature pigs. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

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]

3. United States pubmed.ncbi.nlm.nih.gov

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]

4. United States pubmed.ncbi.nlm.nih.gov

The effect of the selective cytopheretic device on acute kidney injury outcomes in the intensive care unit: a multicenter pilot study. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

The effects of a novel therapeutic device on acute kidney injury outcomes in the intensive care unit: a pilot study. [2015]