Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Kidney Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01400893
Recruitment Status : Terminated
First Posted : July 25, 2011
Results First Posted : August 29, 2017
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):
CytoPherx, Inc

Tracking Information
First Submitted Date  ICMJE July 21, 2011
First Posted Date  ICMJE July 25, 2011
Results First Submitted Date  ICMJE March 14, 2017
Results First Posted Date  ICMJE August 29, 2017
Last Update Posted Date September 27, 2017
Study Start Date  ICMJE August 2011
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2011)
The Primary Clinical Efficacy endpoint in this trial is time to all-cause mortality through 60 days post-randomization. [ Time Frame: Day 60 following treatment end ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2017)
Renal Replacement Therapy Dependency at Day 60. [ Time Frame: Day 60 following treatment initiation ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2011)
  • Renal Replacement Therapy Dependency at Day 60. [ Time Frame: 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.
  • Number of ventilator free days (VFD) at day 28. [ Time Frame: Day 28 following treatment ]
    Ventilator Free Days (VFD) to day 28 is defined as the number of days of unassisted breathing to day 28 after randomization, assuming a patient survives for at least two consecutive calendar days after initiating unassisted breathing and remains free of assisted breathing.
  • Mortality at day 28 [ Time Frame: Day 28 following treatment ]
  • Mortality of Severe Septic patient sub-population at day 60 [ Time Frame: Day 60 following treatment ]
  • Number of vasopressor free days during Observation and post-Observation periods. [ Time Frame: Up to 7 days following treatment ]
    The number of days a patient is free from vasopressor support during the Observation (treatment) and Post-Observation Periods. The post-Observation period may last up to 7 days.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Kidney Injury
Official Title  ICMJE 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)
Brief 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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Kidney Injury
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: CRRT + SCD
    Patients with a diagnosis of AKI requires CRRT will be randomized
    Intervention: Device: SCD
  • No Intervention: CRRT alone
    Patients with a diagnosis of AKI requires CRRT will be randomized
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 4, 2014)
134
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2011)
344
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 18 to 80 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. Must be receiving and tolerating CRRT therapy for a minimum of 4 hours, but not longer than 24.
  6. Expected to remain in the ICU for at least 96 hours after evaluation for enrollment.
  7. 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.)
  8. Presence of at least one non-renal organ failure or present sepsis as defined in Appendix C.
  9. All patients must be able to tolerate regional citrate anticoagulation.

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.
  4. Presence of preexisting advanced chronic renal failure (i.e., ESRD) requiring chronic renal replacement therapy prior to this episode of acute kidney injury.
  5. 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.
  6. Metastatic malignancy which is actively being treated or may be treated by chemotherapy or radiation during the subsequent three month period after study therapy.
  7. 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.
  8. Severe liver failure as documented by a Child-Pugh Liver Failure Score >12 (see Appendix F).
  9. Currently in Do Not Resuscitate (DNR) status or DNR status anticipated within the next 7 days.
  10. Currently in Comfort measures Only or Comfort Measures Only status anticipated within next 7 days.
  11. Patient is moribund or chronically debilitated for whom full supportive care is not indicated.
  12. 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.)
  13. Any medical condition that the Investigator thinks may interfere with the study objectives.
  14. Physician refusal.
  15. Patient is a prisoner.
  16. Dry weight of >150 kg.
  17. More than one hemodialysis treatment during this hospital admission or prior to transfer from an outside hospital.
  18. Platelet count <30,000/mm3 at time of screening.
  19. 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.
  20. Use of any other Investigational drug or device within the previous 30 days.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01400893
Other Study ID Numbers  ICMJE SCD-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CytoPherx, Inc
Study Sponsor  ICMJE CytoPherx, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CytoPherx, Inc
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP