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

• ClinicalTrials.gov Identifier: NCT03539861
• Recruitment Status: Recruiting
• First Posted: May 29, 2018
• Last Update Posted: June 21, 2021
• Sponsor: University of Michigan
• Collaborator: Renal Research Institute
• Information provided by (Responsible Party): Lenar Yessayan, University of Michigan

Study Description

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.

Condition or disease	Intervention/treatment	Phase
End Stage Renal Disease; Acute Kidney Injury; Chronic Kidney Disease Stage 5	Device: Hemodialysis	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients (ERSD)
• Actual Study Start Date: September 24, 2019
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: December 2022

Arms and Interventions

Arm	Intervention/treatment
Hemodialysis; 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; 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.; Other Names: Selective cytopheretic device; SCD; SCD filter anticoagulated with regional citrate

Outcome Measures

Primary Outcome Measures :

1. Change in regional wall abnormalities identified on echocardiogram [ Time Frame: Baseline, 5 hour, 24 hours ]
   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.

Secondary Outcome Measures :

1. Number of participants with an adverse event based on the Clinical laboratory measurement: ionized calcium (iCa) [ Time Frame: Hour 1, hour 2, hour 3, hour 4, hour 5 ]
   Descriptive analysis
2. Number of participants with an adverse event based on the Clinical laboratory measurement: Hemoglobin [ Time Frame: Baseline, Hour 5, 24 hours ]
   Descriptive analysis

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Contacts

Contact: Lenar Yessayan; 734-763-9041; lenar@umich.edu

Locations

United States, Michigan

The University of Michigan; Recruiting

Ann Arbor, Michigan, United States, 48109

Contact: Amie Anderson

Sponsors and Collaborators

University of Michigan

Renal Research Institute

Investigators

• Principal Investigator: Lenar Yessayan; The University of Michigan Department of Internal Medicine

More Information

• Responsible Party: Lenar Yessayan, Associate Professor of Internal Medicine, Medical School, University of Michigan
• ClinicalTrials.gov Identifier: NCT03539861
• Other Study ID Numbers: HUM00125836
• First Posted: May 29, 2018
• Last Update Posted: June 21, 2021
• Last Verified: June 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Lenar Yessayan, University of Michigan:

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

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Acute Kidney Injury; Kidney Failure, Chronic; Myocardial Stunning; Urologic Diseases; Renal Insufficiency; Heart Diseases; Cardiovascular Diseases