Acute Renal FailureNCT01072682
Safety Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Renal Failure
A study testing Selective cytopheretic device (SCD) in people with Acute Renal Failure, run by SeaStar Medical at 7 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 renal failure (ARF). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Renal Failure
- What is being tested?
- Selective cytopheretic device (SCD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 7 sitesUnited States
- Study dates
- Feb 2010to May 2011
- 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, Mixed, other).
- 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 hours.
- 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 renal failure 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.)
- At least one non-renal organ failure (modified SOFA organ system score >2), as defined in Appendix A or presence (proven or suspected) of sepsis as defined in Appendix B.
- All patients must be able to tolerate regional citrate anticoagulation.
Who cannot join
- Contraindications to regional citrate anticoagulation.
- Irreversible brain damage based on available historical and clinical information.
- Presence of a renal transplant at any time.
- Non-candidacy for acute renal replacement therapy.
- Non-renal organ transplantation within six months of screening date.
- Presence of preexisting chronic renal failure prior to this episode of ARF. Preexisting chronic renal failure is defined as baseline serum creatinine >2.5 mg/dL (men), or >2.0 mg/dL (women).
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- ARF 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
- Chronic immunosuppression (e.g., AIDS, chronic glucocorticoid therapy >20 mg/day prednisone equivalent on a chronic basis, or chemotherapy). The acute use of glucocorticoids is permissible
- Severe liver failure as documented by a Child-Pugh Liver Failure Score >12.
- Do Not Resuscitate (DNR) status.
- Comfort measures only.
- Patient is moribund or for whom full supportive care is not indicated.
- Patient not expected to survive 28 days because of an irreversible medical condition.
- Any medical condition that the Investigator thinks may interfere with the study objectives.
- Physician refusal.
- Patient pregnant.
- Patient is a prisoner.
- Pre-morbid weight >128.5 kg.
- More than one hemodialysis treatment or longer than 24 hours since starting CRRT.
- Platelet count <30,000/mm3.
- Concurrent enrollment in another interventional clinical trial. Patients enrolled in clinical trials where only measurements and or samples are taken (NO TEST DEVICE OR DRUG USED) are allowed to participate.
- Use of any other Investigational drug or device within the previous 30 days.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Alabama Birmingham
Birmingham, Alabama, 35294
Memorial Hospital
Chattanooga, Tennessee, 37404
Denver Nephrology
Denver, Colorado, 80230
University of Texas
Houston, Texas, 77030
Mayo Clinic
Rochester, Minnesota, 55905
University of California San Diego
San Diego, California, 92103
George Washington University
Washington D.C., District of Columbia, 20037
About this study
Official title: A Multi-Center Pilot Study to Assess the Safety and Efficacy of A Selective Cytopheretic Device (SCD) Treatments In Patients With Acute Renal Failure (ARF)
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 renal failure (ARF).
Read the detailed description
Acute renal failure 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 Renal Failure
- Being tested
- Selective cytopheretic device (SCD)
- Keywords
- Acute Renal Failure, Acute tubular necrosis, Continuous Renal Replacement Therapy, Selective cytopheretic device
- Medical subject headings
- Acute Kidney Injury, Kidney Cortex Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective cytopheretic device (SCD)Device
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 |
|---|---|---|
| SCD | Experimental | Selective Cytopheretic Device Receives: Device: Selective cytopheretic device (SCD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
60 Day Mortality
Measured: Day 60 following treatment end
60 Day Renal Recovery
The criteria used to measure Renal Recovery requires the patient to be dependent free of CRRT and/or chronic dialysis.
Measured: Day 60 following treatment end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2011
- Study completionMay 2011
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.
- Other trials for Acute Renal FailureStudies 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- SeaStar Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baim Institute for Clinical Research, Medtox
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072682
- Sponsor's protocol ID
- ARF002
- Status last verified
- Mar 2022
- First submitted
- 17 Feb 2010
- Last updated
- 31 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. 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) Treatments In Patients With Acute Renal Failure (ARF)
- ClinicalTrials.gov ID
- NCT01072682
- Acronym / sponsor ID
- ARF002
- Conditions
- Acute Renal Failure
- Keywords
- Acute Renal Failure, Acute tubular necrosis, Continuous Renal Replacement Therapy, Selective cytopheretic device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- SeaStar MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Baim Institute for Clinical Research, Medtox
- Study start
- Feb 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 22 Feb 2010 (estimated)
- Results
- Posted 9 Mar 2022
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 renal failure (ARF).
Detailed description
Acute renal failure 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCD | Experimental | Device: Selective cytopheretic device (SCD)Selective Cytopheretic Device |
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, Mixed, other).
- 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 hours.
Key exclusion criteria (23 listed)
- Contraindications to regional citrate anticoagulation.
- Irreversible brain damage based on available historical and clinical information.
- Presence of a renal transplant at any time.
- Non-candidacy for acute renal replacement therapy.
- Non-renal organ transplantation within six months of screening date.
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 |
|---|---|---|
| Selective cytopheretic device (SCD)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. | Device | SCD |
Primary outcome
60 Day Mortality
Time frame: Day 60 following treatment end
60 Day Renal Recovery
Time frame: Day 60 following treatment end
The criteria used to measure Renal Recovery requires the patient to be dependent free of CRRT and/or chronic dialysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective cytopheretic device (SCD) in people with Acute Renal Failure, run by SeaStar Medical at 7 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 23 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 9 Mar 2022). 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?
60 Day Mortality (time frame: Day 60 following treatment end). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2022.