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

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: Terminated
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Device: Selective Cytopheretic Device

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: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Length of Stay	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	Total days each participant spends in an ICU during the primary admission	From enrollment to Day 60 post treatment
Mortality	Mortality rate as a percent of all participants treated with the SCD	Day 28 post treatment
Renal Recovery	Percent of patients free from chronic dialysis treatments	Day 28 post treatment
Mortality	Mortality rate as a percent of all participants treated with the SCD	Day 60 post treatment
Renal Recovery	Percent of patients free from chronic dialysis treatments	Day 60 post treatment

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Actual): October 27, 2023
• Study Completion (Actual): October 27, 2023

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Acute Kidney Injury
• Other Study ID 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