Acute Kidney InjuryNCT01400893
Efficacy Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Kidney Injury
A study testing SCD in people with Acute Kidney Injury, run by SeaStar Medical at 26 sites in United States.
Trial summary
The purpose of this protocol is to evaluate the safety of a selective cytopheretic device (SCD) in patients that are on continuous renal replacement therapy (CRRT) for acute kidney injury (AKI). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- SCD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 26 sitesUnited States
- Study dates
- Aug 2011to Sep 2013
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older 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 18 to 80 years.
- Females of child bearing potential who are not pregnant (confirmed by a negative serum pregnancy test) and not lactating if recently post-partum.
- Must be receiving and tolerating CRRT therapy for a minimum of 4 hours, but not longer than 24.
- Expected to remain in the ICU for at least 96 hours after evaluation for enrollment.
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- A clinical diagnosis of ATN due to hemodynamic or toxic etiologies. ATN is defined as Acute Kidney Injury occurring in a setting of acute ischemic or nephrotoxic injury with oliguria (average <20 mL/hr) for >6-12 hours or: an increase in serum creatinine ≥2 mg/dL (≥1.5 mg/dL in females) over a period of ≤4 days. (Note: Prerenal, hepatorenal, vascular, interstitial, glomerular, and obstructive etiologies are excluded on clinical or other diagnostic grounds.)
- Presence of at least one non-renal organ failure or present sepsis as defined in Appendix C.
- All patients must be able to tolerate regional citrate anticoagulation.
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.
- Presence of preexisting advanced chronic renal failure (i.e., ESRD) requiring chronic renal replacement therapy prior to this episode of acute kidney injury.
- AKI occurring in the setting of burns, obstructive uropathy, allergic interstitial nephritis, acute or rapidly progressive glomerulonephritis, vasculitis, hemolytic-uremic syndrome, thrombotic thrombocytopenic purpura (TTP), malignant hypertension, scleroderma renal crisis, atheroembolism, functional or surgical nephrectomy, hepatorenal syndrome, 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.
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- Chronic immunosuppression (e.g., HIV/AIDS, chronic glucocorticoid therapy >20 mg/day prednisone equivalent on a chronic basis). The acute use of glucocorticoids is permissible.
- Severe liver failure as documented by a Child-Pugh Liver Failure Score >12 (see Appendix F).
- Currently in Do Not Resuscitate (DNR) status or DNR status anticipated within the next 7 days.
- Currently in Comfort measures Only or Comfort Measures Only status anticipated within 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.
- Patient is a prisoner.
- Dry weight of >150 kg.
- More than one hemodialysis treatment during this hospital admission or prior to transfer from an outside hospital.
- Platelet count <30,000/mm3 at time of screening.
- 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.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Albany Medical College
Albany, New York, 12208
University of Maryland
Baltimore, Maryland, 21201
University of Alabama Birmingham
Birmingham, Alabama, 35233
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, 02215
Medical University Of South Carolina
Charleston, South Carolina, 29425
Memorial Hospital
Chattanooga, Tennessee, 37403
Erlanger Hospital
Chattanooga, Tennessee, 37404
Northwestern University
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
Dallas VA Medical Center
Dallas, Texas, 75216
Henry Ford Hospital
Detroit, Michigan, 48202
INOVA Health Care Services
Falls Church, Virginia, 22042
Sanford Health
Fargo, North Dakota, 58122
University of Florida
Gainesville, Florida, 32611
University of Texas
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
University of Mississippi
Jackson, Mississippi, 39216
University of Florida
Jacksonville, Florida, 32209
UCLA
Los Angeles, California, 90025
University of Wisconsin
Madison, Wisconsin, 53792
Mount Sinai School of Medicine
New York, New York, 10029
Virginia Commonwealth University
Richmond, Virginia, 23298
University of California, San Diego
San Diego, California, 92103
Baystate Medical Center
Springfield, Massachusetts, 01199
Washington University
St Louis, Missouri, 63110
About this study
Official title: A Multi-Center, Randomized, Controlled, Pivotal Study To Assess the Safety and Efficacy of A Selective Cytopheretic Device (SCD) In Patients With Acute Kidney Injury (AKI)
The purpose of this protocol is to evaluate the safety of a selective cytopheretic device (SCD) in patients that are on continuous renal replacement therapy (CRRT) for acute kidney injury (AKI).
Read the detailed description
Acute kidney injury is a condition where the kidneys are not capable of producing adequate urine. Therefore, another way to remove waste from the body is needed to hopefully allow time for the kidneys to heal. One method of removing waste from the body is called Continuous Renal Replacement Therapy (CRRT) or variations of that therapy. This study will evaluate the safety of the device while it is connected to the CRRT tubing for up to 7 days. Patients will be followed up until day 60 following the treatment.
- Conditions
- Acute Kidney Injury
- Being tested
- SCD
- Keywords
- Acute Renal Failure, Acute kidney injury, Acute tubular necrosis, Continuous Renal Replacement Therapy, Severe sepsis, Selective cytopheretic device
- Medical subject headings
- Acute Kidney Injury, Kidney Cortex Necrosis, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCDDevice
The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter 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 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 group | Role | What they receive |
|---|---|---|
| CRRT + SCD | Experimental | Patients with a diagnosis of AKI requires CRRT will be randomized Receives: Device: SCD |
| CRRT alone | No intervention | Patients with a diagnosis of AKI requires CRRT will be randomized |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Clinical Efficacy Endpoint in This Trial is All Cause Mortality Through 60 Days Post-randomization.
All cause mortality through day 60 post-randomization.
The outcome data reported here describe the mortality at Day 60 (primary endpoint) of the treated subjects which received the recommended ionized calcium (riCa) for ≥ 90% of treatment time.
Measured: Day 60 following treatment initiation
Secondary outcomes (1)
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: Day 60 following treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2013
- Study completionSep 2013
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- SeaStar Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400893
- Sponsor's protocol ID
- SCD-003
- Status last verified
- Apr 2021
- First submitted
- 21 Jul 2011
- Last updated
- 27 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Tumlin JA, Galphin CM, Tolwani AJ, Chan MR, Vijayan A, Finkel K, Szamosfalvi B, Dev D, DaSilva JR, Astor BC, Yevzlin AS, Humes HD; SCD Investigator Group. A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients with Acute Kidney Injury. PLoS One. 2015 Aug 5;10(8):e0132482. doi: 10.1371/journal.pone.0132482. eCollection 2015.
PubMed 26244978
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Controlled, Pivotal Study To Assess the Safety and Efficacy of A Selective Cytopheretic Device (SCD) In Patients With Acute Kidney Injury (AKI)
- ClinicalTrials.gov ID
- NCT01400893
- Acronym / sponsor ID
- SCD-003
- Conditions
- Acute Kidney Injury
- Keywords
- Acute Renal Failure, Acute kidney injury, Acute tubular necrosis, Continuous Renal Replacement Therapy, Severe sepsis, Selective cytopheretic device
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 134 participants (actual)
- Lead sponsor
- SeaStar MedicalIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 25 Jul 2011 (estimated)
- Results
- Posted 29 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this protocol is to evaluate the safety of a selective cytopheretic device (SCD) in patients that are on continuous renal replacement therapy (CRRT) for acute kidney injury (AKI).
Detailed description
Acute kidney injury is a condition where the kidneys are not capable of producing adequate urine. Therefore, another way to remove waste from the body is needed to hopefully allow time for the kidneys to heal. One method of removing waste from the body is called Continuous Renal Replacement Therapy (CRRT) or variations of that therapy. This study will evaluate the safety of the device while it is connected to the CRRT tubing for up to 7 days. Patients will be followed up until day 60 following the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRRT + SCD | Experimental | Device: SCDPatients with a diagnosis of AKI requires CRRT will be randomized |
| CRRT alone | No intervention | –Patients with a diagnosis of AKI requires CRRT will be randomized |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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 18 to 80 years.
- Females of child bearing potential who are not pregnant (confirmed by a negative serum pregnancy test) and not lactating if recently post-partum.
- Must be receiving and tolerating CRRT therapy for a minimum of 4 hours, but not longer than 24.
Key exclusion criteria (20 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.
- Presence of preexisting advanced chronic renal failure (i.e., ESRD) requiring chronic renal replacement therapy prior to this episode of acute kidney injury.
- AKI occurring in the setting of burns, obstructive uropathy, allergic interstitial nephritis, acute or rapidly progressive glomerulonephritis, vasculitis, hemolytic-uremic syndrome, 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 |
|---|---|---|
| SCDThe selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter 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 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. | Device | CRRT + SCD |
Primary outcome
The Primary Clinical Efficacy Endpoint in This Trial is All Cause Mortality Through 60 Days Post-randomization.
Time frame: Day 60 following treatment initiation
All cause mortality through day 60 post-randomization. The outcome data reported here describe the mortality at Day 60 (primary endpoint) of the treated subjects which received the recommended ionized calcium (riCa) for ≥ 90% of treatment time.
1 secondary outcome
Renal Replacement Therapy Dependency at Day 60.
Time frame: Day 60 following treatment initiation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26244978Tumlin JA, Galphin CM, Tolwani AJ, Chan MR, Vijayan A, Finkel K, Szamosfalvi B, Dev D, DaSilva JR, Astor BC, Yevzlin AS, Humes HD; SCD Investigator Group. A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients with Acute Kidney Injury. PLoS One. 2015 Aug 5;10(8):e0132482. doi: 10.1371/journal.pone.0132482. eCollection 2015.
- Related InfoLink provided by the sponsor.
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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.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCD in people with Acute Kidney Injury, run by SeaStar Medical at 26 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 9 inclusion and 20 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: stopped early, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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 29 Aug 2017). 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?
The Primary Clinical Efficacy Endpoint in This Trial is All Cause Mortality Through 60 Days Post-randomization. (time frame: Day 60 following 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 NCT01400893, 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 27 Apr 2021.