Trial Outcomes & Findings for A Multi-Center Study of a SCD for Immunomodulatory Dysregulation in Pediatric AKI (NCT NCT04869787)

NCT ID: NCT04869787

Last Updated: 2024-01-10

Results Overview

Total number of AEs across all participants that are considered to be at least possibly related to SCD therapy per the site investigator

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 7 participants
• Primary outcome timeframe: From enrollment to Day 60 post treatment
• Results posted on: 2024-01-10

Participant Flow

After consent was obtained, participants entered the screening period. If their clinical status changed and the investigator believed that they no longer met eligibility criteria, the participant would be recorded as a screen failure. Criteria this may impact included resuscitation status, hypotension, platelet count, medical condition that the investigator thought would interfere with study objectives. or treating physician believed it was not longer in the patient's best interest.

Participant milestones

Measure	SCD Treatment Pediatric patients receiving SCD + CRRT for up to 10 days Selective Cytopheretic Device: SCD in line with CRRT extracorporeal device
Screening STARTED	7
Screening COMPLETED	6
Screening NOT COMPLETED	1
SCD Treatment Period (up to 10 Days) STARTED	6
SCD Treatment Period (up to 10 Days) COMPLETED	5
SCD Treatment Period (up to 10 Days) NOT COMPLETED	1
Observational Follow Up Period (90 Days) STARTED	5
Observational Follow Up Period (90 Days) COMPLETED	5
Observational Follow Up Period (90 Days) NOT COMPLETED	0

Reasons for withdrawal

Measure	SCD Treatment Pediatric patients receiving SCD + CRRT for up to 10 days Selective Cytopheretic Device: SCD in line with CRRT extracorporeal device
Screening Physician Decision	1
SCD Treatment Period (up to 10 Days) Death	1

Baseline Characteristics

A Multi-Center Study of a SCD for Immunomodulatory Dysregulation in Pediatric AKI

Baseline characteristics by cohort

Measure	SCD Treatment n=6 Participants Pediatric patients receiving SCD + CRRT for up to 10 days Selective Cytopheretic Device: SCD in line with CRRT extracorporeal device
Age, Continuous	2.05 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Body Weight, Continuous	13.4 kilograms n=5 Participants
Pediatric Risk of Mortality II Score	16.5 Scores on a scale n=5 Participants

PRIMARY outcome

Timeframe: From enrollment to Day 60 post treatment

Population: Participants who received treatment with the SCD

Total number of AEs across all participants that are considered to be at least possibly related to SCD therapy per the site investigator

Outcome measures

Measure	SCD Treatment n=6 Participants Pediatric patients receiving SCD + CRRT for up to 10 days Selective Cytopheretic Device: SCD in line with CRRT extracorporeal device
Number of SCD-related Adverse Events (AE)	1 Events

PRIMARY outcome

Timeframe: From enrollment to Day 60 post treatment

Population: Participants who received treatment with the SCD

Total number of UADEs across all participants treated with the SCD

Outcome measures

Measure	SCD Treatment n=6 Participants Pediatric patients receiving SCD + CRRT for up to 10 days Selective Cytopheretic Device: SCD in line with CRRT extracorporeal device
Number of Unanticipated Adverse Device Effects (UADE)	0 Events

SECONDARY outcome

Timeframe: Day 28 post treatment

Population: Participants who received treatment with the SCD

Mortality rate as a percent of all participants treated with the SCD

Outcome measures

Measure	SCD Treatment n=6 Participants Pediatric patients receiving SCD + CRRT for up to 10 days Selective Cytopheretic Device: SCD in line with CRRT extracorporeal device
Mortality	1 Participants

SECONDARY outcome

Timeframe: Day 28 post treatment

Population: Participants who received treatment with the SCD and who survived to Day 28 post treatment

Percent of patients free from chronic dialysis treatments

Outcome measures

Measure	SCD Treatment n=5 Participants Pediatric patients receiving SCD + CRRT for up to 10 days Selective Cytopheretic Device: SCD in line with CRRT extracorporeal device
Renal Recovery	5 Participants

SECONDARY outcome

Timeframe: From enrollment to Day 60 post treatment

Population: Participants who received treatment with SCD, survived to hospital discharge, and were discharged prior to the last study visit (Day 60)

Total days each participant spends as an inpatient at an acute care facility

Outcome measures

Measure	SCD Treatment n=2 Participants Pediatric patients receiving SCD + CRRT for up to 10 days Selective Cytopheretic Device: SCD in line with CRRT extracorporeal device
Hospital Length of Stay	24 Days Interval 23.0 to 25.0

SECONDARY outcome

Timeframe: From enrollment to Day 60 post treatment

Population: Participants who received treatment with the SCD, survived to Day 60, and were ICU discharged by the last study visit (Day 60)

Total days each participant spends in an ICU during the primary admission

Outcome measures

Measure	SCD Treatment n=4 Participants Pediatric patients receiving SCD + CRRT for up to 10 days Selective Cytopheretic Device: SCD in line with CRRT extracorporeal device
Intensive Care Unit (ICU) Length of Stay	11.5 Days Interval 10.0 to 24.0

SECONDARY outcome

Timeframe: Day 60 post treatment

Population: Participants who received treatment with the SCD

Mortality rate as a percent of all participants treated with the SCD

Outcome measures

Measure	SCD Treatment n=6 Participants Pediatric patients receiving SCD + CRRT for up to 10 days Selective Cytopheretic Device: SCD in line with CRRT extracorporeal device
Mortality	1 Participants

SECONDARY outcome

Timeframe: Day 60 post treatment

Population: Participants who received treatment with the SCD and who survived to Day 60 post treatment

Percent of patients free from chronic dialysis treatments

Outcome measures

Measure	SCD Treatment n=5 Participants Pediatric patients receiving SCD + CRRT for up to 10 days Selective Cytopheretic Device: SCD in line with CRRT extracorporeal device
Renal Recovery	5 Participants

Adverse Events

SCD Treatment

Serious events: 2 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Measure	SCD Treatment n=6 participants at risk Pediatric patients receiving SCD + CRRT for up to 10 days Selective Cytopheretic Device: SCD in line with CRRT extracorporeal device
Respiratory, thoracic and mediastinal disorders Pneumothorax	16.7% 1/6 • Number of events 1 • 60 Days During the screening period, only adverse events directly related to screening procedures were captured. Serious adverse events were monitored for and collected between SCD start and Day 60 after enrollment for each participants. Non-serious adverse events were recorded from SCD start until 120 hours after SCD treatment ends, death, subject withdrawal of study consent, or ICU discharge, whichever occurs first.
Injury, poisoning and procedural complications Medical device site thrombosis	16.7% 1/6 • Number of events 1 • 60 Days During the screening period, only adverse events directly related to screening procedures were captured. Serious adverse events were monitored for and collected between SCD start and Day 60 after enrollment for each participants. Non-serious adverse events were recorded from SCD start until 120 hours after SCD treatment ends, death, subject withdrawal of study consent, or ICU discharge, whichever occurs first.
Cardiac disorders Cardiac arrest	16.7% 1/6 • Number of events 1 • 60 Days During the screening period, only adverse events directly related to screening procedures were captured. Serious adverse events were monitored for and collected between SCD start and Day 60 after enrollment for each participants. Non-serious adverse events were recorded from SCD start until 120 hours after SCD treatment ends, death, subject withdrawal of study consent, or ICU discharge, whichever occurs first.
Infections and infestations Septic shock	16.7% 1/6 • Number of events 1 • 60 Days During the screening period, only adverse events directly related to screening procedures were captured. Serious adverse events were monitored for and collected between SCD start and Day 60 after enrollment for each participants. Non-serious adverse events were recorded from SCD start until 120 hours after SCD treatment ends, death, subject withdrawal of study consent, or ICU discharge, whichever occurs first.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	16.7% 1/6 • Number of events 1 • 60 Days During the screening period, only adverse events directly related to screening procedures were captured. Serious adverse events were monitored for and collected between SCD start and Day 60 after enrollment for each participants. Non-serious adverse events were recorded from SCD start until 120 hours after SCD treatment ends, death, subject withdrawal of study consent, or ICU discharge, whichever occurs first.
Metabolism and nutrition disorders Lactic acidosis	16.7% 1/6 • Number of events 1 • 60 Days During the screening period, only adverse events directly related to screening procedures were captured. Serious adverse events were monitored for and collected between SCD start and Day 60 after enrollment for each participants. Non-serious adverse events were recorded from SCD start until 120 hours after SCD treatment ends, death, subject withdrawal of study consent, or ICU discharge, whichever occurs first.

Other adverse events

Measure	SCD Treatment n=6 participants at risk Pediatric patients receiving SCD + CRRT for up to 10 days Selective Cytopheretic Device: SCD in line with CRRT extracorporeal device
Blood and lymphatic system disorders Anemia	16.7% 1/6 • Number of events 1 • 60 Days During the screening period, only adverse events directly related to screening procedures were captured. Serious adverse events were monitored for and collected between SCD start and Day 60 after enrollment for each participants. Non-serious adverse events were recorded from SCD start until 120 hours after SCD treatment ends, death, subject withdrawal of study consent, or ICU discharge, whichever occurs first.
Blood and lymphatic system disorders Coagulopathy	16.7% 1/6 • Number of events 1 • 60 Days During the screening period, only adverse events directly related to screening procedures were captured. Serious adverse events were monitored for and collected between SCD start and Day 60 after enrollment for each participants. Non-serious adverse events were recorded from SCD start until 120 hours after SCD treatment ends, death, subject withdrawal of study consent, or ICU discharge, whichever occurs first.
Blood and lymphatic system disorders Thrombocytopenia	50.0% 3/6 • Number of events 3 • 60 Days During the screening period, only adverse events directly related to screening procedures were captured. Serious adverse events were monitored for and collected between SCD start and Day 60 after enrollment for each participants. Non-serious adverse events were recorded from SCD start until 120 hours after SCD treatment ends, death, subject withdrawal of study consent, or ICU discharge, whichever occurs first.
Hepatobiliary disorders Hyperbilirubinemia	33.3% 2/6 • Number of events 2 • 60 Days During the screening period, only adverse events directly related to screening procedures were captured. Serious adverse events were monitored for and collected between SCD start and Day 60 after enrollment for each participants. Non-serious adverse events were recorded from SCD start until 120 hours after SCD treatment ends, death, subject withdrawal of study consent, or ICU discharge, whichever occurs first.
Investigations Blood bicarbonate decreased	16.7% 1/6 • Number of events 1 • 60 Days During the screening period, only adverse events directly related to screening procedures were captured. Serious adverse events were monitored for and collected between SCD start and Day 60 after enrollment for each participants. Non-serious adverse events were recorded from SCD start until 120 hours after SCD treatment ends, death, subject withdrawal of study consent, or ICU discharge, whichever occurs first.
Investigations Blood fibrinogen decreased	16.7% 1/6 • Number of events 1 • 60 Days During the screening period, only adverse events directly related to screening procedures were captured. Serious adverse events were monitored for and collected between SCD start and Day 60 after enrollment for each participants. Non-serious adverse events were recorded from SCD start until 120 hours after SCD treatment ends, death, subject withdrawal of study consent, or ICU discharge, whichever occurs first.
Investigations White blood cell count increased	16.7% 1/6 • Number of events 1 • 60 Days During the screening period, only adverse events directly related to screening procedures were captured. Serious adverse events were monitored for and collected between SCD start and Day 60 after enrollment for each participants. Non-serious adverse events were recorded from SCD start until 120 hours after SCD treatment ends, death, subject withdrawal of study consent, or ICU discharge, whichever occurs first.
Metabolism and nutrition disorders Hypercalcemia	16.7% 1/6 • Number of events 1 • 60 Days During the screening period, only adverse events directly related to screening procedures were captured. Serious adverse events were monitored for and collected between SCD start and Day 60 after enrollment for each participants. Non-serious adverse events were recorded from SCD start until 120 hours after SCD treatment ends, death, subject withdrawal of study consent, or ICU discharge, whichever occurs first.
Metabolism and nutrition disorders Hyperkalemia	16.7% 1/6 • Number of events 1 • 60 Days During the screening period, only adverse events directly related to screening procedures were captured. Serious adverse events were monitored for and collected between SCD start and Day 60 after enrollment for each participants. Non-serious adverse events were recorded from SCD start until 120 hours after SCD treatment ends, death, subject withdrawal of study consent, or ICU discharge, whichever occurs first.
Metabolism and nutrition disorders Hypernatremia	16.7% 1/6 • Number of events 1 • 60 Days During the screening period, only adverse events directly related to screening procedures were captured. Serious adverse events were monitored for and collected between SCD start and Day 60 after enrollment for each participants. Non-serious adverse events were recorded from SCD start until 120 hours after SCD treatment ends, death, subject withdrawal of study consent, or ICU discharge, whichever occurs first.
Metabolism and nutrition disorders Hypertriglyceridemia	16.7% 1/6 • Number of events 1 • 60 Days During the screening period, only adverse events directly related to screening procedures were captured. Serious adverse events were monitored for and collected between SCD start and Day 60 after enrollment for each participants. Non-serious adverse events were recorded from SCD start until 120 hours after SCD treatment ends, death, subject withdrawal of study consent, or ICU discharge, whichever occurs first.
Metabolism and nutrition disorders Hypoalbuminemia	16.7% 1/6 • Number of events 1 • 60 Days During the screening period, only adverse events directly related to screening procedures were captured. Serious adverse events were monitored for and collected between SCD start and Day 60 after enrollment for each participants. Non-serious adverse events were recorded from SCD start until 120 hours after SCD treatment ends, death, subject withdrawal of study consent, or ICU discharge, whichever occurs first.
Metabolism and nutrition disorders Hypokalemia	50.0% 3/6 • Number of events 3 • 60 Days During the screening period, only adverse events directly related to screening procedures were captured. Serious adverse events were monitored for and collected between SCD start and Day 60 after enrollment for each participants. Non-serious adverse events were recorded from SCD start until 120 hours after SCD treatment ends, death, subject withdrawal of study consent, or ICU discharge, whichever occurs first.
Metabolism and nutrition disorders Hypomagnesemia	16.7% 1/6 • Number of events 1 • 60 Days During the screening period, only adverse events directly related to screening procedures were captured. Serious adverse events were monitored for and collected between SCD start and Day 60 after enrollment for each participants. Non-serious adverse events were recorded from SCD start until 120 hours after SCD treatment ends, death, subject withdrawal of study consent, or ICU discharge, whichever occurs first.
Metabolism and nutrition disorders Hypophosphatemia	33.3% 2/6 • Number of events 2 • 60 Days During the screening period, only adverse events directly related to screening procedures were captured. Serious adverse events were monitored for and collected between SCD start and Day 60 after enrollment for each participants. Non-serious adverse events were recorded from SCD start until 120 hours after SCD treatment ends, death, subject withdrawal of study consent, or ICU discharge, whichever occurs first.
Nervous system disorders Cerebral dysfunction	16.7% 1/6 • Number of events 1 • 60 Days During the screening period, only adverse events directly related to screening procedures were captured. Serious adverse events were monitored for and collected between SCD start and Day 60 after enrollment for each participants. Non-serious adverse events were recorded from SCD start until 120 hours after SCD treatment ends, death, subject withdrawal of study consent, or ICU discharge, whichever occurs first.
Product Issues Device leakage	16.7% 1/6 • Number of events 1 • 60 Days During the screening period, only adverse events directly related to screening procedures were captured. Serious adverse events were monitored for and collected between SCD start and Day 60 after enrollment for each participants. Non-serious adverse events were recorded from SCD start until 120 hours after SCD treatment ends, death, subject withdrawal of study consent, or ICU discharge, whichever occurs first.

Additional Information

Dr. Stuart L.Goldstein

Cincinnati Children's Hospital Medical Center

Phone: 513-636-4837

Email: stuart.goldstein@cchmc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place