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

NCT ID: NCT04898010

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-09
• Study Completion Date: 2027-10-31

Brief 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.

Conditions

Acute Kidney Injury; Hepatorenal Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Selective Cytopheretic Device

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

Group Type: EXPERIMENTAL

Selective Cytopheretic Device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lenar Yessayan

OTHER

Sponsor Role: lead

Responsible Party

Lenar Yessayan

Associate Professor of Internal Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lenar Yessayan

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37643314 (View on PubMed)

Other Identifiers

HUM00163117

Identifier Type: -

Identifier Source: org_study_id