Trial Outcomes & Findings for Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients (NCT NCT03539861)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

Baseline, 5 hour, 24 hours

Results posted on

2023-01-17

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hemodialysis n=2 Participants 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. 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.
Age, Customized 25-30	1 Participants n=5 Participants
Age, Customized 62-68	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race/Ethnicity, Customized White	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African-American	1 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 5 hour, 24 hours

Population: Regional wall motion was not able to be evaluated for one participant because of arrhythmia. Because sharing data about the other individual could violate privacy concerns, it is not analyzed or displayed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Number of participants who experienced a clinically significant change in systemic ionized calcium compared to reference range: 1.12 to 1.30.

Outcome measures

Outcome measures
Measure	Hemodialysis n=2 Participants 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. 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.
Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Ionized Calcium (iCa)	0 Participants

SECONDARY outcome

Timeframe: Baseline, Hour 5, 24 hours

Number of participants who experienced a clinically significant change in hemoglobin who experience a change of more than 10% of baseline

Outcome measures

Outcome measures
Measure	Hemodialysis n=2 Participants 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. 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.
Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Hemoglobin	0 Participants

Adverse Events

Hemodialysis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lenar Yessayan

University of Michigan

Phone: 734-763-9041

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place