Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI). (SCD-PED-01)

A Multi-Center, Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI)

The SCD (Selective Cytopheretic Device) is an extracorporeal device used as an adjunct to renal replacement therapy (RRT) to improve the outcomes of pediatric patients with acute kidney injury (AKI). Funding Source - FDA OOPD (SCD-PED-01)

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Device: SCD-F40

Detailed Description

The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to commercially available Continuous Renal Replacement Therapy (CRRT) devices. 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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Children's Hospital of Alabama
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta at Egleston
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • CS Mott Children's Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 22 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. A patient, or legal representative, has signed a written informed consent form.
2. Must be receiving medical care in an intensive care unit (e.g., ICU, MICU, SICU, CTICU, Trauma).
3. Age less than 22 years.
4. Females of child bearing potential who are not pregnant (confirmed by a negative serum pregnancy test) and not lactating if recently post-partum.
5. Intent to deliver full supportive care through aggressive management utilizing all available therapies for a minimum of 96 hours.

6. Clinical diagnosis of AKI due to etiologies requiring CRRT (see Appendix B). AKI is defined as acute kidney injury with any one of the following:

   • Increase in SCr by ≥0.3 mg/dL (≥26.5 μmol/L) within 48 hours or;
   • Increase in SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days or;
   • Urine volume <0.5ml/kg/h for 6 hours
7. At least one non-renal organ failure (defined as receiving mechanical ventilation or at least one vasoactive medication to treat hypotension) OR presence (proven or suspected) of sepsis. (Appendix C).

Exclusion Criteria:

1. Irreversible brain damage based on available historical and clinical information.
2. Presence of any organ transplant at any time.
3. Acute or chronic use of circulatory support device such as LVADs, RVADs, BIVADs, ECMO(a).
4. Presence of preexisting advanced chronic renal failure (i.e., ESRD) requiring CRRT prior to this episode of AKI.
5. AKI occurring in the setting of burns, obstructive uropathy, allergic interstitial nephritis, acute or rapidly progressive glomerulonephritis, vasculitis, hemolytic-uremic syndrome(b), thrombotic thrombocytopenic purpura (TTP), malignant hypertension, scleroderma renal crisis, atheroembolism, functional or surgical nephrectomy, hepatorenal syndrome, cyclosporine, or tacrolimus nephrotoxicity
6. Received >12hrs of CRRT during this hospital admission or prior to transfer from an outside hospital.
7. Received >1 hemodialysis treatment during this hospital admission or prior to transfer from an outside hospital.
8. Hospitalization >14 days during this hospital admission and or prior to transfer from an outside hospital.
9. Metastatic malignancy which is actively being treated or may be treated by chemotherapy or radiation during the subsequent three-month period after study therapy.
10. Chronic immunosuppression.
11. HIV or AIDS.
12. Severe liver failure(c).
13. 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.
14. Patient is moribund or chronically debilitated for whom full supportive care is not indicated.
15. Patient not expected to survive 28 days because of an irreversible medical condition. (This is not restrictive to AKI, and may include situations such as the presence of irreversible brain damage, untreatable malignancy, inoperable life threatening condition, or any condition to which therapy is regarded as futile by the PI.)
16. Any medical condition that the Investigator thinks may interfere with the study objectives.
17. Physician refusal.
18. Dry weight of <20kg(d).
19. Platelet count <30,000/mm3 at time of screening(e).
20. Concurrent enrollment in another interventional clinical trial. Patients enrolled in clinical trials where only measurements and/or samples are taken (NO TEST DEVICE OR TEST DRUG USED) are allowed to participate.

21. Use of any other Investigational drug or device within the previous 30 days.

    1. ECMO was subsequently removed as an exclusion. Two patients in the study received ECMO.
    2. Hemolytic uremic syndrome subsequently removed as an exclusion. One patient in the study had HUS.
    3. Severe liver failure was change to severe chronic liver failure during the study course.
    4. The lower weight limit threshold was decreased to 15 kg after consultation and approval from the US FDA.
    5. The thrombocytopenia exclusion removed after no observed occurrences in the first five subjects.

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: Treatment; Treatment arm only	Device: SCD-F40; CRRT with SCD; Other Names: Selective Cytopheretic Device (SCD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Adverse events related to device treatment occurring during and 60 days post treatment initiation	60 days post treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All Cause Mortality Through 60 Days Post-randomization.	The effect of SCD treatment on all cause mortality through 60 days post-randomization.	Day 60
Mortality at Day 28	Mortality at day 28 following treatment	Day 28 following treatment
The Effect of SCD Treatment on Renal Replacement Therapy Dependency at Day 60.	RRT dependency at day 60 is defined as patient not receiving any form of intermittent or continuous renal replacement therapy at 60 days post enrollment in the study with no plans for additional intermittent or continuous renal replacement therapy.	60 days

Collaborators and Investigators

• Sponsor: CytoPherx, Inc
• Collaborators: Children's Hospital Medical Center, Cincinnati; Innovative BioTherapies (IBT)

Publications and helpful links

General Publications

• Goldstein SL, Askenazi DJ, Basu RK, Selewski DT, Paden ML, Krallman KA, Kirby CL, Mottes TA, Terrell T, Humes HD. Use of the Selective Cytopheretic Device in Critically Ill Children. Kidney Int Rep. 2020 Dec 19;6(3):775-784. doi: 10.1016/j.ekir.2020.12.010. eCollection 2021 Mar.

Helpful Links

• Digital Object Identifier)

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2016
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: June 7, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimated): June 30, 2016

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Pediatric; Acute kidney injury; Acute Renal Failure; Continuous Renal Replacement Therapy; Selective cytopheretic device
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: SCD-PED-01; FD005092-01 (Other Grant/Funding Number: FDA OOPD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO