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Immunomodulatory Device

Hemodialysis for Acute Kidney Injury (ESRD Trial)

N/A
Waitlist Available
Led By Lenar Yessayan
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up hour 1, hour 2, hour 3, hour 4, hour 5
Awards & highlights

ESRD Trial Summary

This trial will test whether a new device that filters blood during dialysis can reduce heart muscle injury.

Eligible Conditions
  • Acute Kidney Injury
  • Kidney Failure
  • Renal Disease

ESRD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~hour 1, hour 2, hour 3, hour 4, hour 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and hour 1, hour 2, hour 3, hour 4, hour 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Regional Wall Abnormalities Identified on Echocardiogram
Secondary outcome measures
Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Hemoglobin
Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Ionized Calcium (iCa)

Side effects data

From 2021 Phase 3 trial • 51 Patients • NCT03740048
41%
hospitalization
5%
Hospitalization
100%
80%
60%
40%
20%
0%
Study treatment Arm
Conventional Hemodialysis Regimen
Hemodialysis and Pharmacologic Therapy

ESRD Trial Design

1Treatment groups
Experimental Treatment
Group I: HemodialysisExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hemodialysis
2008
Completed Phase 4
~1900

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,795 Previous Clinical Trials
6,373,934 Total Patients Enrolled
11 Trials studying Acute Kidney Injury
12,963 Patients Enrolled for Acute Kidney Injury
Renal Research InstituteOTHER
34 Previous Clinical Trials
79,412 Total Patients Enrolled
Lenar YessayanPrincipal Investigator - The University of Michigan Department of Internal Medicine
University of Michigan C.S. Mott Children's Hospital, University of Michigan Hospital, Von Voigtlander Women's Hospital
American University Of Beirut (Medical School)
Henry Ford Hospital (Residency)
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Acute Kidney Injury
10 Patients Enrolled for Acute Kidney Injury

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients
Lenar Yessayan 2019. "Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03539861.
~0 spots leftby Apr 2025
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