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

October 2, 2025 updated by: Lenar Yessayan

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Selective Cytopheretic Device
Subjects will be placed on Selective Cytopheretic Device (SCD) for planned daily 24 hour therapy for up to 7 consecutive days.
Device: Selective Cytopheretic Device
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of serious adverse events related to selective cytopheretic device (SCD)
Time Frame: Up to 90 days
Up to 90 days
Number of deaths related to selective cytopheretic device
Time Frame: Up to 90 days
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
Up to 7 days
Number of unforeseen malfunction(s) that results in the need for discontinuation
Time Frame: Up to 7 days
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
Up to 7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dialysis independence
Time Frame: Up to 90 (+/- 7 days)
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.
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)
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).
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)
Measured by blood tests of liver function parameters such as AST, ALT, alkaline phosphatase
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).
Measured by blood test of bilirubin
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).
Coagulation parameters include Prothrombin Time (PT), Activated Partial Thromboplastin Time (PTT), and International Normalized Ratio (INR) all reported in seconds
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).
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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lenar Yessayan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lenar Yessayan, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 9, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUM00163117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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