Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients

NCT03539861 | Terminated Results FDA Device

• 1 other identifier: HUM00125836
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Hemodialysis is a therapy that filters waste, removes extra fluid and balances electrolytes. In hemodialysis, blood is removed from the body and filtered through a man-made membrane called a dialyzer, and then the filtered blood is returned to the body. Hemodialysis is associated with injury to the heart muscle called myocardial stunning. This may occur for many reasons, including removal of fluid during dialysis or low blood pressure. Initial ischemia and subsequent white blood cell infiltration into the injured myocardium play a critical role in the degree of myocardial ischemia reperfusion injury. In this study an additional man made membrane (selective cytopheretic device) and tubing will be added to the dialysis circuit. The device shifts the circulating white blood cells pool to a less inflammatory phenotype. Researchers believe the selective cytopheretic device will alter the phenotype of circulating white blood cells which play a role in myocardial stunning. The purpose of this study is to evaluate whether the selective cytopheretic device will reduce myocardial stunning events in hemodialysis patients. It will also report the rate of adverse events.

Conditions

End Stage Renal Disease; Acute Kidney Injury; Chronic Kidney Disease Stage 5

Keywords

End Stage Renal Disease; Hemodialysis; Chronic Kidney Disease Stage 5

Outcome Measures

Primary Outcomes (1)

• Change in Regional Wall Abnormalities Identified on Echocardiogram

  Regional wall motion will be scored using a standard wall motion scoring scheme. (1= normal; 2=hypokinetic; 3= akinetic; 4=dyskinetic). Scores will be tabulated for each of 16 predefined segments and a global wall motion score calculated as the sum of individual scores divided by the number visualized segments.

  Baseline, 5 hour, 24 hours

Secondary Outcomes (2)

• Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Ionized Calcium (iCa)

  Hour 1, hour 2, hour 3, hour 4, hour 5

• Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Hemoglobin

  Baseline, Hour 5, 24 hours

Study Arms (1)

Hemodialysis

OTHER

The treatment arm (all participants are in this arm) is done in two phases that are described below: Treatment 1 will be standard hemodialysis (no device). Treatment 2 will be hemodialysis with the study device. Of importance, this 5 hour session is planned to ensure adequate solute clearance but with only 4 hour high ultrafiltration to achieve the patients dry weight.

Device: Hemodialysis

Interventions

Hemodialysis DEVICE

Each patient will receive two hemodialysis treatments while on this study. The first hemodialysis treatment will be standard of care hemodialysis. The second treatment will be the experimental hemodialysis treatment using the Selective cytopheretic device.

Also known as: Selective cytopheretic device, SCD, SCD filter anticoagulated with regional citrate

Hemodialysis

Eligibility Criteria

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

You may qualify if:

• End-stage renal disease (Chronic Kidney Disease Stage 5)
• Receiving hemodialysis 3 times/week for over 3 months
• Baseline blood pressure before hemodialysis has been ≥ 100/50 over preceding 4 weeks
• Recurrent weight gain between hemodialysis sessions

You may not qualify if:

• Any active inflammatory condition (e.g., gout, systemic lupus erythematosus flare, hepatitis B or C infection, allograft rejection, subcutaneous injection of illicit drugs, "skin popping")
• Treatment with immunosuppressive therapy within 30 days of study
• Blood levels within a specified range
• Woman who is pregnant, breast feeding a child, or is trying to become pregnant
• Heart weakness or failure

Sponsors & Collaborators

• University of Michigan: lead
• Renal Research Institute: collaborator

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Acute Kidney Injury; Renal Insufficiency, Chronic

Interventions

Renal Dialysis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Sorption Detoxification

Results Point of Contact

• Title: Lenar Yessayan
• Organization: University of Michigan

lenar@med.umich.edu

734-763-9041

Study Officials

• Lenar Yessayan

  The University of Michigan Department of Internal Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: May 29, 2018
• Study Start: September 24, 2019
• Primary Completion: August 4, 2021
• Study Completion: August 4, 2021
• Last Updated: January 17, 2023
• Results First Posted: January 17, 2023

Record last verified: 2022-11

Locations

US (1)