SCD for Acute Kidney Injury and Hepatorenal Syndrome

Overseen By Angela Westover

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lenar Yessayan

Must not be taking: Nephrotoxic medications

Disqualifiers: Chronic kidney disease, MELD score > 40, 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: 37

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with hepatorenal syndrome, a kidney problem often found in those with severe liver issues. The focus is on the Selective Cytopheretic Device (SCD) to determine if it can improve kidney function and blood circulation over seven days. Suitable candidates include individuals with cirrhosis and worsening kidney issues who have not improved with standard treatments and are receiving care in an intensive care unit. As an unphased trial, this study provides a unique opportunity to access innovative treatment options not yet widely available.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that you should not be on nephrotoxic medications (drugs harmful to the kidneys) and should not have been using any investigational drugs or devices in the past 30 days.

What prior data suggests that the Selective Cytopheretic Device is safe for patients with hepatorenal syndrome?

Studies have shown that the Selective Cytopheretic Device (SCD) is safe to use. Research indicates that the device did not cause harmful side effects in patients. Other studies found that SCD therapy is safe and likely beneficial for both adults and children with acute kidney injury (AKI). This suggests the device is generally well-tolerated by patients. For those considering joining a trial with the SCD, the safety data appears promising. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for acute kidney injury and hepatorenal syndrome, which often involve medications and dialysis, the Selective Cytopheretic Device (SCD) offers a novel approach by directly targeting cells involved in the inflammatory response. This device works by filtering out harmful immune cells from the blood, potentially reducing inflammation and allowing the kidneys to recover more effectively. Researchers are excited about the SCD because it provides a non-pharmaceutical option that might work faster and more efficiently, offering new hope for patients with these challenging conditions.

What evidence suggests that the Selective Cytopheretic Device is effective for hepatorenal syndrome?

Research has shown that the Selective Cytopheretic Device (SCD), which participants in this trial will receive, yields promising results for patients with acute kidney injury (AKI). It has been associated with a significant reduction in death rates, which often exceed 50% in ICU patients with AKI. One study demonstrated that the SCD improved survival rates to 76% at both Day 28 and Day 60, and 71% at Day 90. The FDA has approved the device for treating life-threatening AKI caused by severe infections, known as sepsis. These findings suggest that the SCD may enhance kidney function and survival in patients with hepatorenal syndrome, a condition where kidney failure occurs due to severe liver disease. ^{1 3 6 7 8}

Who Is on the Research Team?

Lenar Yessayan, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for adults with cirrhosis and ascites who have Hepatorenal Syndrome Type I without improvement after specific treatments, can tolerate certain therapies, and are in intensive care. Excluded are those with organ transplants, severe heart disease, HIV/AIDS, high risk of dying within 90 days (MELD score >40), or on other clinical trials.

Inclusion Criteria

My worsening kidney failure is likely due to Type I Hepatorenal Syndrome with a low GFR.

My kidney function hasn't improved with octreotide/midodrine, or I can't tolerate them.

I can undergo a specific blood thinning treatment and kidney support therapy for more than a day.

Exclusion Criteria

You are currently using a device to help your heart pump blood.

Use of any other investigational drug or device within the previous 30 days

Your platelet count is less than 30,000 per cubic millimeter.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Selective Cytopheretic Device (SCD) therapy for up to 7 consecutive days

1 week

Daily visits for 7 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in coagulation parameters, liver function, and renal function

90 days

Visits at days 30 and 90

What Are the Treatments Tested in This Trial?

Interventions

• Selective Cytopheretic Device

Trial Overview The study tests the Selective Cytopheretic Device (SCD) over a week to see its effects on white blood cells in the bloodstream, circulation, and kidney function in patients with hepatorenal syndrome.

How Is the Trial Designed?

Group I: Selective Cytopheretic Device Experimental Treatment 1 Intervention

Subjects will be placed on Selective Cytopheretic Device (SCD) for planned daily 24 hour therapy for up to 7 consecutive days.

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?

Lenar Yessayan

Lead Sponsor

Trials

3

Recruited

40+

Published Research Related to This Trial

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 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]

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]

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]

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]

Citations

1. investors.seastarmedical.com investors.seastarmedical.com/news-releases/news-release-details/seastar-medical-reports-positive-early-results-quelimmune

Release Details In addition, outcomes analyses show a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90. These new data are on track to ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02820350?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22CytoPherx,%20Inc%22)&viewType=Table&rank=1

Safety and Efficacy of a Selective Cytopheretic Device ... Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI). (SCD-PED-01) · Study Overview · Contacts and ...

3. investors.seastarmedical.com investors.seastarmedical.com/node/9876/pdf

SeaStar Medical to Present Early SAVE Registry Data of ... It is the only FDA approved product for the ultra-rare condition of life-threatening acute kidney injury (AKI) due to sepsis or a septic ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10589552/

Safety Summary of the Selective Cytopheretic Device Acute kidney injury (AKI) requiring continuous kidney replacement therapy is a significant complication in ICU patients with mortality rates exceeding 50%.

5. tandfonline.com tandfonline.com/doi/full/10.1080/13696998.2025.2550860

Projected hospitalization cost impact of the selective ... Modeled hospitalization costs were $389,451 in the ppCRRT comparison group and $320,304 in the SCD-PED group, reflecting an estimated savings of $69,146 per ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02820350

Safety and Efficacy of a Selective Cytopheretic Device ... Intent to deliver full supportive care through aggressive management utilizing all available therapies for a minimum of 96 hours. Clinical diagnosis of AKI due ...

7. fda.gov fda.gov/media/176749/download

QUELIMMUNE The SCD-PED is intended to be used to treat pediatric patients ≥10 kg with acute kidney injury due to sepsis or a septic condition on antibiotic ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2590059524000037

Selective Cytopheretic Device Use in Continuous Kidney ... The SCD therapy is feasible, safe, and demonstrates probable benefit for critically ill children who require CRRT for AKI.