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

NCT04869787 | Terminated Results DMC FDA Device

• 1 other identifier: SCD PED-02
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (2)

• Number of SCD-related Adverse Events (AE)

  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)

  Total number of UADEs across all participants treated with the SCD

  From enrollment to Day 60 post treatment

Secondary Outcomes (6)

• Mortality

  Day 28 post treatment

• Renal Recovery

  Day 28 post treatment

• Hospital Length of Stay

  From enrollment to Day 60 post treatment

• Intensive Care Unit (ICU) Length of Stay

  From enrollment to Day 60 post treatment

• Mortality

  Day 60 post treatment

Study Arms (1)

SCD Treatment

OTHER

Pediatric patients receiving SCD + CRRT for up to 10 days

Device: Selective Cytopheretic Device

Interventions

Selective Cytopheretic Device DEVICE

SCD in line with CRRT extracorporeal device

Also known as: SCD-F40

SCD Treatment

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Threshold blood pressure of 80/40 mmHg
• 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
• Acute or chronic use of circulatory support device, other than extracorporeal membrane oxygenation (ECMO)
• 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
• AKI occurring in the setting of burns, obstructive uropathy, scleroderma renal crisis, atheroembolism, functional or surgical nephrectomy, cyclosporine or tacrolimus nephrotoxicity
• Metastatic malignancy which is actively being treated or may be treated by chemotherapy or radiation during the subsequent three month period after study therapy
• Chronic immunosuppression with the exception of corticosteroids up to a dose of 10 mg of prednisone per day
• Known positive HIV or AIDS or COVID-19
• 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
• Patient not expected to survive 28 days because of an irreversible medical condition
• Any medical condition that the Investigator thinks may interfere with the study objectives
• Treating clinician does not feel it is in the best interest of the patient
• Platelet count \<15,000/mm3
• Concurrent enrollment in another interventional clinical trial
• Use of any other investigational drug or device within the previous 30 days

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• University of Michigan: collaborator

Study Sites (2)

Children's of Alabama

Birmingham, Alabama, 35233, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

This trial was terminated early in preparations for a HDE approval from the FDA for this population. This trial represents a small subject populations from only 2 centers in the US.

Results Point of Contact

• Title: Dr. Stuart L.Goldstein
• Organization: Cincinnati Children's Hospital Medical Center

stuart.goldstein@cchmc.org

513-636-4837

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Acute Care Nephrology

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 3, 2021
• Study Start: May 17, 2021
• Primary Completion: October 27, 2023
• Study Completion: October 27, 2023
• Last Updated: January 10, 2024
• Results First Posted: January 10, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)