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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is being done to learn what effect 7 days of treatment with the Selective Cytopheretic Device (SCD) will have on these white blood cells in the bloodstream of patients with hepatorenal syndrome and to learn whether it has any effect on the blood circulation and kidney function.

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 data supports the effectiveness of the treatment Selective Cytopheretic Device for Acute Kidney Injury and Hepatorenal Syndrome?

Research shows that the Selective Cytopheretic Device (SCD) has been effective in reducing mortality rates in patients with acute kidney injury (AKI) in intensive care units. In one study, mortality dropped from 77.78% in the control group to 22.22% in the SCD treatment group, and patients experienced improved kidney function, as seen by increased urine output. ^{1 2 3 4 5}

Is the Selective Cytopheretic Device (SCD) safe for use in humans?

The Selective Cytopheretic Device (SCD) has been studied in clinical trials for conditions like acute kidney injury in ICU patients, showing a significant reduction in mortality rates compared to historical controls, suggesting it is generally safe. However, further studies are needed to confirm its safety and effectiveness. ^{1 2 3 4 5}

How is the Selective Cytopheretic Device treatment different from other treatments for acute kidney injury?

The Selective Cytopheretic Device (SCD) is unique because it targets and modulates the activity of specific immune cells (leukocytes) that drive inflammation, unlike other treatments that may not address this immune response. This novel approach aims to reduce systemic inflammation and improve outcomes in patients with acute kidney injury. ^{1 2 3 4 5}

Research Team

Lenar Yessayan, MD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

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]

3. 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]

4. 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]

5. 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]