SCD-PED-01: A Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI).

Sponsor

CytoPherx, Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT02820350

Collaborator

Innovative BioTherapies (IBT) (Other), Children's Hospital Medical Center, Cincinnati (Other)

Enrollment

Locations

39.9

Actual Duration (Months)

7.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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)

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	Device: SCD-F40	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Dec 4, 2016

Actual Primary Completion Date :

Mar 31, 2020

Actual Study Completion Date :

Mar 31, 2020

Outcome Measures

Primary Outcome Measures

Primary Objective: Adverse events related to treatment occurring during and 60 days post treatment initiation. [60 days]
The primary clinical endpoint in this trial is safety of SCD treatment after up to seven consecutive 24 hour therapy sessions. Safety as determined with adverse events related to treatment up to 60 days following treatment initiation.

Secondary Outcome Measures

The effect of SCD treatment on all cause mortality through 60 days post-randomization. [Day 60 following treatment end]
The effect of SCD treatment on all cause mortality through 60 days post-randomization.
The effect of SCD treatment on Renal Replacement Therapy dependency at day 60. [Day 60 following treatment end]
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.
Mortality at day 28 [Day 28 following treatment]
Mortality at day 28 following treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 22 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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:

Threshold blood pressure of 80/40 mmHg-- patients with both a systolic blood pressure of less than 80 mmHg and a diastolic blood pressure of less than 40 mmHg.
Irreversible brain damage based on available historical and clinical information.
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 ECMO such as LVADs, RVADs, BIVADs.
Presence of preexisting advanced chronic renal failure (i.e., ESRD) requiring chronic renal replacement therapy prior to this episode of acute kidney injury or with pre-existing chronic kidney disease (CKD) defined as a eGFR<30ml/min/1.73m2. Patients who have never seen a pediatric nephrologist will be assumed not to have pre-existing CKD.
AKI occurring in the setting of burns, obstructive uropathy, scleroderma renal crisis, atheroembolism, functional or surgical nephrectomy, cyclosporine, or tacrolimus nephrotoxicity.
Received >12 hour of CRRT (not including SCUF on ECMO) during this hospital admission or prior to transfer from an outside hospital.
Received >1 hemodialysis treatment during this hospital admission or prior to transfer from an outside hospital.
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 10mg per day.
HIV or AIDS.
Severe chronic liver failure as determined by standard diagnostic requirements.
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. (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.)
Any medical condition that the Investigator thinks may interfere with the study objectives.
Physician refusal.
Dry weight of <15 kg.
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.
Use of any other Investigational drug or device within the previous 30 days. -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Alabama	Birmingham	Alabama	United States	35233
2	Children's Healthcare of Atlanta at Egleston	Atlanta	Georgia	United States	30322
3	CS Mott Children's Hospital	Ann Arbor	Michigan	United States	48109
4	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229