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

NCT04898010 | Suspended FDA Device

• 1 other identifier: HUM00163117
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

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

  Up to 90 days

• Number of deaths related to selective cytopheretic device

  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

  Up to 7 days

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

  Up to 7 days

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

  Up to 7 days

Secondary Outcomes (6)

• Dialysis independence

  Up to 90 (+/- 7 days)

• Change in renal function

  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

  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

  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

  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).

Study Arms (1)

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.

Device: Selective Cytopheretic Device

Interventions

Selective Cytopheretic Device 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.

Selective Cytopheretic Device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lenar Yessayan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 37643314 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; Hepatorenal Syndrome

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Liver Diseases; Digestive System Diseases

Study Officials

• Lenar Yessayan

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 24, 2021
• Study Start: June 9, 2022
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)