Acute Kidney InjurySCD-PED-01NCT02820350
Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI).
A study testing SCD-F40 in people with Acute Kidney Injury, run by CytoPherx, Inc at 4 sites in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 2 to 22 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- SCD-F40
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 4 sitesUnited States
- Study dates
- 4 Dec 2016to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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:
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- 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).
Who cannot join
- Irreversible brain damage based on available historical and clinical information.
- Presence of any organ transplant at any time.
- Acute or chronic use of circulatory support device such as LVADs, RVADs, BIVADs, ECMO(a).
- Presence of preexisting advanced chronic renal failure (i.e., ESRD) requiring CRRT prior to this episode of AKI.
- 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
- Received >12hrs of CRRT during this hospital admission or prior to transfer from an outside hospital.
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- Received >1 hemodialysis treatment during this hospital admission or prior to transfer from an outside hospital.
- Hospitalization >14 days during this hospital admission and 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.
- HIV or AIDS.
- Severe liver failure(c).
- 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 is moribund or chronically debilitated for whom full supportive care is not indicated.
- 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 <20kg(d).
- Platelet count <30,000/mm3 at time of screening(e).
- 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.
- ECMO was subsequently removed as an exclusion. Two patients in the study received ECMO.
- Hemolytic uremic syndrome subsequently removed as an exclusion. One patient in the study had HUS.
- Severe liver failure was change to severe chronic liver failure during the study course.
- The lower weight limit threshold was decreased to 15 kg after consultation and approval from the US FDA.
- The thrombocytopenia exclusion removed after no observed occurrences in the first five subjects.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
CS Mott Children's Hospital
Ann Arbor, Michigan, 48109
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322
Children's Hospital of Alabama
Birmingham, Alabama, 35233
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
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)
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)
Read the 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.
- Conditions
- Acute Kidney Injury
- Being tested
- SCD-F40
- Keywords
- Acute Renal Failure, Acute kidney injury, Continuous Renal Replacement Therapy, Selective cytopheretic device, Pediatric
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCD-F40Device
Also called Selective Cytopheretic Device (SCD)
CRRT with SCD
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Treatment arm only Receives: Device: SCD-F40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Adverse events related to device treatment occurring during and 60 days post treatment initiation
Measured: 60 days post treatment initiation
Secondary outcomes (3)
All Cause Mortality Through 60 Days Post-randomization.
The effect of SCD treatment on all cause mortality through 60 days post-randomization.
Measured: Day 60
Mortality at Day 28
Mortality at day 28 following treatment
Measured: 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.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study start4 Dec 2016
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- CytoPherx, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innovative BioTherapies (IBT), Children's Hospital Medical Center, Cincinnati
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820350
- Sponsor's protocol ID
- SCD-PED-01
- Other IDs
- FD005092-01
- Acronym
- SCD-PED-01
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2016
- Last updated
- 20 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 33732992
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02820350
- Acronym / sponsor ID
- SCD-PED-01 / SCD-PED-01
- Conditions
- Acute Kidney Injury
- Keywords
- Acute Renal Failure, Acute kidney injury, Continuous Renal Replacement Therapy, Selective cytopheretic device, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- CytoPherx, IncIndustry (pharma, biotech, devices)
- Collaborators
- Innovative BioTherapies (IBT), Children's Hospital Medical Center, Cincinnati
- Study start
- 4 Dec 2016 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Posted 20 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Device: SCD-F40Treatment arm only |
Who may qualify
- Ages
- 2 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (26 listed)
- Irreversible brain damage based on available historical and clinical information.
- Presence of any organ transplant at any time.
- Acute or chronic use of circulatory support device such as LVADs, RVADs, BIVADs, ECMO(a).
- Presence of preexisting advanced chronic renal failure (i.e., ESRD) requiring CRRT prior to this episode of AKI.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCD-F40Also: Selective Cytopheretic Device (SCD)CRRT with SCD | Device | Treatment |
Primary outcome
Adverse Events
Time frame: 60 days post treatment initiation
Adverse events related to device treatment occurring during and 60 days post treatment initiation
3 secondary outcomes
All Cause Mortality Through 60 Days Post-randomization.
Time frame: Day 60
Mortality at Day 28
Time frame: Day 28 following treatment
The Effect of SCD Treatment on Renal Replacement Therapy Dependency at Day 60.
Time frame: 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33732992Goldstein 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.
- Digital Object Identifier)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCD-F40 in people with Acute Kidney Injury, run by CytoPherx, Inc at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 60 days post treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02820350, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.