A Multi-Center Study of a SCD for Immunomodulatory Dysregulation in Pediatric AKI (SCD PED-02)

December 19, 2023 updated by: Stuart Goldstein, MD, Children's Hospital Medical Center, Cincinnati

A Multi-Center, Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) for the Treatment of Immunomodulatory Dysregulation Due to Pediatric Acute Kidney Injury (AKI)

The SCD PED-02 trial is examining the safety and efficacy of the Selective Cytopheretic Device (SCD) in treating pediatric acute kidney injury (AKI). AKI promotes a systemic inflammatory response syndrome (SIRS) which results in systemic microvascular damage and, if severe, multi-organ dysfunction. Activated circulating leukocytes play a central role in this process. The SCD is a synthetic membrane with the ability to bind activated leukocytes and, when used in a continuous renal replacement therapy (CRRT) extracorporeal circuit in the presence of regional citrate anticoagulation, modulates inflammation. The SCD PED-02 study will test the primary hypothesis that up to ten sequential 24-hour SCD treatments in pediatric patients with AKI will be completed safely and improve survival compared to historical controls who received CRRT alone.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The SCD PED-02 trial is examining the safety and efficacy of the Selective Cytopheretic Device (SCD) in treating pediatric acute kidney injury (AKI). Importantly, acute kidney injury is a highly lethal condition in critically ill patients. Despite improvements in acute medical care and advances in dialysis therapies, the mortality rate during the past four decades of this condition has not improved. Critically ill patients with AKI in hospital ICU settings have mortality rates of approximately 50%, including pediatric patients. AKI promotes a systemic inflammatory response syndrome (SIRS) which results in systemic microvascular damage and, if severe, multi-organ dysfunction. Activated circulating leukocytes play a central role in this process. Leukocytes, especially neutrophils, are major contributors to the pathogenesis and progression of many inflammatory disorders, including SIRS, sepsis, ischemia reperfusion injury, and acute respiratory distress syndrome (ARDS). Many therapeutic approaches are under investigation to limit the activation and tissue accumulation of leukocytes at sites of inflammation to minimize tissue destruction and disease progression.

The SCD is comprised of tubing, connectors, and a synthetic membrane cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and it is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits. The SCD is a synthetic membrane with the ability to bind activated leukocytes and, when used in a continuous renal replacement therapy (CRRT) extracorporeal circuit in the presence of regional citrate anticoagulation, modulates inflammation.

The SCD PED-02 study will test the primary hypothesis that up to ten sequential 24-hour SCD treatments in pediatric patients with AKI will be completed safely and improve survival compared to historical controls who received CRRT alone.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Children's of Alabama
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The patient's parent or legal representative has provided informed consent
  2. Must be receiving medical care in an intensive care unit
  3. Age less than 18 years.
  4. Body weight between ≥10 and ≤ 20 kilograms
  5. Intent to receive full supportive care through aggressive management
  6. Clinical diagnosis of AKI requiring CRRT
  7. At least one non-renal organ failure OR presence of proven/suspected sepsis

Exclusion Criteria:

  1. Threshold blood pressure of 80/40 mmHg
  2. Patients with a solid organ transplant or those with a bone marrow or stem cell transplant in the previous 100 days or who have not engrafted
  3. Acute or chronic use of circulatory support device, other than extracorporeal membrane oxygenation (ECMO)
  4. Presence of preexisting advanced chronic renal failure on chronic renal replacement therapy or with an estimated glomerular filtration rate less than 30 mL/min/1.73m2
  5. AKI occurring in the setting of burns, obstructive uropathy, scleroderma renal crisis, atheroembolism, functional or surgical nephrectomy, cyclosporine or tacrolimus nephrotoxicity
  6. Metastatic malignancy which is actively being treated or may be treated by chemotherapy or radiation during the subsequent three month period after study therapy
  7. Chronic immunosuppression with the exception of corticosteroids up to a dose of 10 mg of prednisone per day
  8. Known positive HIV or AIDS or COVID-19
  9. Current Do not Attempt Resuscitation (DNAR), Allow Natural Death (AND), or withdrawal of care status, or anticipated change in status within the next 7 days
  10. Patient not expected to survive 28 days because of an irreversible medical condition
  11. Any medical condition that the Investigator thinks may interfere with the study objectives
  12. Treating clinician does not feel it is in the best interest of the patient
  13. Platelet count <15,000/mm3
  14. Concurrent enrollment in another interventional clinical trial
  15. Use of any other investigational drug or device within the previous 30 days
  16. Use of AN-69 hemofilter membrane for CRRT

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: SCD Treatment
Pediatric patients receiving SCD + CRRT for up to 10 days
Device: Selective Cytopheretic Device
SCD in line with CRRT extracorporeal device
Other Names:
  • SCD-F40

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of SCD-related Adverse Events (AE)
Time Frame: From enrollment to Day 60 post treatment
Total number of AEs across all participants that are considered to be at least possibly related to SCD therapy per the site investigator
From enrollment to Day 60 post treatment
Number of Unanticipated Adverse Device Effects (UADE)
Time Frame: From enrollment to Day 60 post treatment
Total number of UADEs across all participants treated with the SCD
From enrollment to Day 60 post treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospital Length of Stay
Time Frame: From enrollment to Day 60 post treatment
Total days each participant spends as an inpatient at an acute care facility
From enrollment to Day 60 post treatment
Intensive Care Unit (ICU) Length of Stay
Time Frame: From enrollment to Day 60 post treatment
Total days each participant spends in an ICU during the primary admission
From enrollment to Day 60 post treatment
Mortality
Time Frame: Day 28 post treatment
Mortality rate as a percent of all participants treated with the SCD
Day 28 post treatment
Renal Recovery
Time Frame: Day 28 post treatment
Percent of patients free from chronic dialysis treatments
Day 28 post treatment
Mortality
Time Frame: Day 60 post treatment
Mortality rate as a percent of all participants treated with the SCD
Day 60 post treatment
Renal Recovery
Time Frame: Day 60 post treatment
Percent of patients free from chronic dialysis treatments
Day 60 post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital Medical Center, Cincinnati

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 27, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 27, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SCD PED-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Dietary Supplements

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