Acute Kidney InjuryNCT04898010
The Selective Cytopheretic Device (SCD) for Acute Kidney Injury (AKI) and Hepatorenal Syndrome (HRS) Type I
A study testing Selective Cytopheretic Device in people with Acute Kidney Injury and Hepatorenal Syndrome, run by Lenar Yessayan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Kidney Injury, Hepatorenal Syndrome
- What is being tested?
- Selective Cytopheretic Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2022to Oct 2029
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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 consecutive days.
- AKI occurring in the setting of burns, obstructive uropathy, allergic interstitial nephritis, acute or rapidly progressive glomerulonephritis, vasculitis, hemolytic uremic syndrome, thrombotic thrombocytopenic purpura (TTP), malignant hypertension, scleroderma renal crisis, atheroembolism, functional or surgical nephrectomy, cyclosporine or tacrolimus nephrotoxicity. No evidence of intrinsic parenchymal renal disorder, ultrasonic evidence of obstructive uropathy or proteinuria greater than 500 mg/day.
- Presence of any organ transplant at any time.
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- Metastatic malignancy which is actively being treated or may be treated by chemotherapy or radiation during the subsequent three-month period after study protocol therapy.
- Severe, uncontrolled cardiac disease.
- Chronic immunosuppression.
- Medical history of HIV or AIDS.
- Current Do Not Attempt Resuscitation (DNAR), Allow Natural Death (AND), or withdrawal of care status, or anticipated change in status within the next 7 days.
- Patient is moribund or chronically debilitated for whom full supportive care is not indicated.
- Dry weight >150 kg.
- Platelet count <30,000/mm3.
- Concurrent enrollment in another interventional clinical trial. Patients enrolled in clinical studies where only measurements and/or samples are taken (i.e., no test device or test drug used) are allowed to participate
- Use of any other investigational drug or device within the previous 30 days
- Patient is a prisoner.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigator Initiated Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) to Treat ICU Patients With Acute Kidney Injury (AKI) and Hepatorenal Syndrome (HRS) Type I
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.
- Conditions
- Acute Kidney Injury, Hepatorenal Syndrome
- Being tested
- Selective Cytopheretic Device
- Medical subject headings
- Acute Kidney Injury, Hepatorenal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Cytopheretic DeviceDevice
The Selective Cytopheretic Device (SCD) treatment will be delivered using a two-cartridge system using a type of dialysis equipment commonly used for conventional hemodialysis therapy. The SCD cartridge will be added immediately post-hemofilter to the circuit of a standard hemodialysis system, and treatment will be delivered for 24 hours. Blood exchange will occur using a dialysis catheter.
| Study group | Role | What they receive |
|---|---|---|
| Selective Cytopheretic Device | Experimental | Subjects will be placed on Selective Cytopheretic Device (SCD) for planned daily 24 hour therapy for up to 7 consecutive days. Receives: Device: Selective Cytopheretic Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of serious adverse events related to selective cytopheretic device (SCD)
Measured: Up to 90 days
Number of deaths related to selective cytopheretic device
Measured: Up to 90 days
Number of events of significant clotting within the device as assessed by visual inspection
Source documentation will record either present, absent, or not-assessed
Measured: Up to 7 days
Number of unforeseen malfunction(s) that results in the need for discontinuation
Measured: Up to 7 days
Number if events with evidence of leakage (i.e., cracking/breakage of a port, connector, SCD casing cartridge or tubing).
Measured: Up to 7 days
Secondary outcomes (6)
Dialysis independence
Dialysis independence at days 1-5 post SCD, and at days 30 and 90 (+/- 7 days). Dialysis independence will be assessed using the medical record.
Measured: Up to 90 (+/- 7 days)
Change in renal function
As measured by serum creatinine from baseline (prior to dialysis initiation) at days 1-5 post SCD and at days 30 and 90 (among survivors and those free from dialysis).
Measured: Baseline (prior to dialysis), days 1-5 post SCD, days 30 and 90 (among survivors and those free from dialysis) (+/- 7 days)
Change in liver function
Measured by blood tests of liver function parameters such as AST, ALT, alkaline phosphatase
Measured: Baseline, at days 1-5 post SCD or until ICU discharge (if earlier than 5 days) and at days 30 and 90 (among survivors)
Change in liver function
Measured by blood test of bilirubin
Measured: Baseline (prior to dialysis), Days 1-5 post SCD or until ICU discharge (if earlier than 5 days) and at days 30 and 90 (among survivors) (+/- 7 days).
Change in coagulation parameters
Coagulation parameters include Prothrombin Time (PT), Activated Partial Thromboplastin Time (PTT), and International Normalized Ratio (INR) all reported in seconds
Measured: Baseline (prior to dialysis), Days 1-5 post SCD or until ICU discharge (if earlier than 5 days) and at days 30 and 90 (among survivors) (+/- 7 days).
Change in model for end-stage liver disease (MELD) score
MELD score is a number that ranges from 6 (least sick) to 40 (most sick) based on blood tests which ranks the degree of sickness from liver disease.
Measured: Baseline (prior to dialysis), Days 1-5 post SCD or until ICU discharge (if earlier than 5 days) and at days 30 and 90 (among survivors) (+/- 7 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start9 Jun 2022
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Why it stopped: On hold while seeking funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lenar Yessayan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lenar Yessayan, University of Michigan
- Investigators
- Lenar Yessayan, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898010
- Sponsor's protocol ID
- HUM00163117
- Status last verified
- Sep 2026
- First submitted
- 18 May 2021
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Yessayan LT, Sharma P, Westover AJ, Szamosfalvi B, Humes HD. Extracorporeal Immunomodulation Therapy in Acute Chronic Liver Failure With Multiorgan Failure: First in Human Use. ASAIO J. 2024 Mar 1;70(3):e53-e56. doi: 10.1097/MAT.0000000000002033. Epub 2023 Aug 29.
PubMed 37643314
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator Initiated Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) to Treat ICU Patients With Acute Kidney Injury (AKI) and Hepatorenal Syndrome (HRS) Type I
- ClinicalTrials.gov ID
- NCT04898010
- Acronym / sponsor ID
- HUM00163117
- Conditions
- Acute Kidney Injury, Hepatorenal Syndrome
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: On hold while seeking funding.
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Lenar YessayanUniversity, hospital or other
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Selective Cytopheretic Device | Experimental | Device: Selective Cytopheretic DeviceSubjects will be placed on Selective Cytopheretic Device (SCD) for planned daily 24 hour therapy for up to 7 consecutive days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (17 listed)
- 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 consecutive days.
- AKI occurring in the setting of burns, obstructive uropathy, allergic interstitial nephritis, acute or rapidly progressive glomerulonephritis, vasculitis, hemolytic uremic syndrome, thrombotic thrombocytopenic purpura (TTP), malignant hypertension, scleroderma renal crisis, atheroembolism, functional or surgical nephrectomy, cyclosporine or tacrolimus nephrotoxicity. No evidence of intrinsic parenchymal renal disorder, ultrasonic evidence of obstructive uropathy or proteinuria greater than 500 mg/day.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective Cytopheretic DeviceThe Selective Cytopheretic Device (SCD) treatment will be delivered using a two-cartridge system using a type of dialysis equipment commonly used for conventional hemodialysis therapy. The SCD cartridge will be added immediately post-hemofilter to the circuit of a standard hemodialysis system, and treatment will be delivered for 24 hours. Blood exchange will occur using a dialysis catheter. | Device | Selective Cytopheretic Device |
Primary outcome
Number of serious adverse events related to selective cytopheretic device (SCD)
Time frame: Up to 90 days
Number of deaths related to selective cytopheretic device
Time frame: Up to 90 days
Number of events of significant clotting within the device as assessed by visual inspection
Time frame: Up to 7 days
Source documentation will record either present, absent, or not-assessed
Number of unforeseen malfunction(s) that results in the need for discontinuation
Time frame: Up to 7 days
Number if events with evidence of leakage (i.e., cracking/breakage of a port, connector, SCD casing cartridge or tubing).
Time frame: Up to 7 days
6 secondary outcomes
Dialysis independence
Time frame: Up to 90 (+/- 7 days)
Change in renal function
Time frame: Baseline (prior to dialysis), days 1-5 post SCD, days 30 and 90 (among survivors and those free from dialysis) (+/- 7 days)
Change in liver function
Time frame: Baseline, at days 1-5 post SCD or until ICU discharge (if earlier than 5 days) and at days 30 and 90 (among survivors)
Change in liver function
Time frame: Baseline (prior to dialysis), Days 1-5 post SCD or until ICU discharge (if earlier than 5 days) and at days 30 and 90 (among survivors) (+/- 7 days).
Change in coagulation parameters
Time frame: Baseline (prior to dialysis), Days 1-5 post SCD or until ICU discharge (if earlier than 5 days) and at days 30 and 90 (among survivors) (+/- 7 days).
Change in model for end-stage liver disease (MELD) score
Time frame: Baseline (prior to dialysis), Days 1-5 post SCD or until ICU discharge (if earlier than 5 days) and at days 30 and 90 (among survivors) (+/- 7 days).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 37643314Yessayan LT, Sharma P, Westover AJ, Szamosfalvi B, Humes HD. Extracorporeal Immunomodulation Therapy in Acute Chronic Liver Failure With Multiorgan Failure: First in Human Use. ASAIO J. 2024 Mar 1;70(3):e53-e56. doi: 10.1097/MAT.0000000000002033. Epub 2023 Aug 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lenar Yessayan principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective Cytopheretic Device in people with Acute Kidney Injury and Hepatorenal Syndrome, run by Lenar Yessayan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of serious adverse events related to selective cytopheretic device (SCD) (time frame: Up to 90 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04898010, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.