SuspendedNot Applicable

The Selective Cytopheretic Device (SCD) for Acute Kidney Injury (AKI) and Hepatorenal Syndrome (HRS) Type I

Stopped: On hold while seeking funding.

United States10 participantsStarted 2022-06-09

Plain-language summary

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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Cirrhosis with ascites. * Not currently listed for liver transplant. * Worsening renal failure most likely due to Hepatorenal Syndrome Type I with low glomerular filtration rate (GFR). * No sustained improvement in renal function after diuretic withdrawal and expansion of plasma volume with 1.5 liters of plasma expander. * No sustained improvement in renal function or intolerant to treatment with octreotide and /or midodrine. * Able to tolerate regional citrate anticoagulation and continuous renal replacement therapy (CRRT) for 24 hours or greater. * Intent to deliver full supportive care through aggressive management utilizing all available therapies for a minimum of 96 hours. * Receiving medical care in an intensive care unit. * Absence of shock, ongoing bacterial infection and fluid losses, and current treatment with nephrotoxic medications, hepatocellular carcinoma. * Females of child bearing potential who are not pregnant (confirmed by a negative serum pregnancy test) and not lactating if recently post-partum. * Two (2) consecutive intra-circuit Ionized Calcium (iCa) levels \<0.40 Millimoles per liter (mmol/L), at least 30 minutes apart. Exclusion Criteria: * Evidence of chronic kidney disease Stage 4. * Patients with Model for End-Stage Liver Disease (MELD) score \> 40 (since these patients are unlikely to survive a 90-day follow-up period). * Acute or chronic use of circulatory support device. * Mechanical ventilation for greater than 7 consecu…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of serious adverse events related to selective cytopheretic device (SCD)

Timeframe: Up to 90 days

Number of deaths related to selective cytopheretic device

Timeframe: Up to 90 days

Number of events of significant clotting within the device as assessed by visual inspection

Timeframe: Up to 7 days

Number of unforeseen malfunction(s) that results in the need for discontinuation

Timeframe: Up to 7 days

Number if events with evidence of leakage (i.e., cracking/breakage of a port, connector, SCD casing cartridge or tubing).

Timeframe: Up to 7 days

Trial details

NCT IDNCT04898010

SponsorLenar Yessayan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10

View on ClinicalTrials.gov More Acute Kidney Injury trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of serious adverse events related to selective cytopheretic device (SCD)

Timeframe: Up to 90 days

Number of deaths related to selective cytopheretic device

Timeframe: Up to 90 days

Number of events of significant clotting within the device as assessed by visual inspection

Timeframe: Up to 7 days

Number of unforeseen malfunction(s) that results in the need for discontinuation

Timeframe: Up to 7 days

Number if events with evidence of leakage (i.e., cracking/breakage of a port, connector, SCD casing cartridge or tubing).

Timeframe: Up to 7 days