End Stage Renal DiseaseESRDNCT03539861
Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients
A study testing Hemodialysis in people with End Stage Renal Disease and Acute Kidney Injury, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Acute Kidney Injury, Chronic Kidney Disease Stage 5
- What is being tested?
- Hemodialysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2019to 4 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients (ERSD)
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.
- Being tested
- Hemodialysis
- Keywords
- End Stage Renal Disease, Hemodialysis, Chronic Kidney Disease Stage 5
- Medical subject headings
- Kidney Failure, Chronic, Acute Kidney Injury, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemodialysisDevice
Also called Selective cytopheretic device, SCD, SCD filter anticoagulated with regional citrate
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 5 hour, 24 hours
Secondary outcomes (2)
Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Ionized Calcium (iCa)
Number of participants who experienced a clinically significant change in systemic ionized calcium compared to reference range: 1.12 to 1.30.
Measured: Hour 1, hour 2, hour 3, hour 4, hour 5
Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Hemoglobin
Number of participants who experienced a clinically significant change in hemoglobin who experience a change of more than 10% of baseline
Measured: Baseline, Hour 5, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start24 Sep 2019
- Primary completion4 Aug 2021
- Study completion4 Aug 2021
Why it stopped: COVID- pandemic, nursing shortages. enrolled two patients then not enough nurses in dialysis unit to be able to attend to patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Renal Research Institute
- Responsible party
- Principal investigator, Lenar Yessayan, University of Michigan
- Investigators
- Lenar Yessayan, Principal investigator, The University of Michigan Department of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539861
- Sponsor's protocol ID
- HUM00125836
- Acronym
- ESRD
- Status last verified
- Nov 2022
- First submitted
- 16 May 2018
- Last updated
- 17 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients (ERSD)
- ClinicalTrials.gov ID
- NCT03539861
- Acronym / sponsor ID
- ESRD / HUM00125836
- Keywords
- End Stage Renal Disease, Hemodialysis, Chronic Kidney Disease Stage 5
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID- pandemic, nursing shortages. enrolled two patients then not enough nurses in dialysis unit to be able to attend to patients
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Renal Research Institute
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 4 Aug 2021 (actual)
- Study completion
- 4 Aug 2021 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Posted 17 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis | Other | Device: HemodialysisThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemodialysisAlso: Selective cytopheretic device, SCD, SCD filter anticoagulated with regional citrateEach 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. | Device | Hemodialysis |
Primary outcome
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.
2 secondary outcomes
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
Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Hemoglobin
Time frame: Baseline, Hour 5, 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lenar Yessayan principal investigator
The University of Michigan Department of Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemodialysis in people with End Stage Renal Disease and Acute Kidney Injury, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Regional Wall Abnormalities Identified on Echocardiogram (time frame: Baseline, 5 hour, 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.