Safety Study of a Selective Cytopheric Device (SCD) in Patients With Acute Renal Failure

This study has been completed.
Sponsor:
Collaborators:
Harvard Clinical Research Institute
Medtox
Information provided by (Responsible Party):
CytoPherx, Inc
ClinicalTrials.gov Identifier:
NCT01072682
First received: February 17, 2010
Last updated: August 31, 2011
Last verified: August 2011
  Purpose

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).


Condition Intervention Phase
Acute Renal Failure
Device: Selective cytopheretic device (SCD)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Further study details as provided by CytoPherx, Inc:

Primary Outcome Measures:
  • To evaluate the safety of the SCD treatment after up to seven consecutive 24 hour SCD treatments compared to historic data on in-hospital mortality and on all cause mortality at day 28, and day 60 following treatment. [ Time Frame: Day 60 following treatment end ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the effect of SCD treatment on various measures of patient clinical outcomes. [ Time Frame: Day 60 following treatment end ] [ Designated as safety issue: No ]
    Recording of clinical values such as vital signs, laboratory tests, adverse events, and the need for further dialysis will be tested.

  • To evaluate the integrity of the SCD device and patient safety in SCD treatments from the time of initiation of therapy to as many as seven consecutive 24-hour SCD treatments. [ Time Frame: Day 60 following treatment end ] [ Designated as safety issue: Yes ]
    This will be done by seeing if the SCD requires changing more often than expected or if there is evidence of clotting.


Enrollment: 35
Study Start Date: February 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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, Mixed, other).
  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 hours.
  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 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.)
  8. 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.
  9. All patients must be able to tolerate regional citrate anticoagulation.

Exclusion Criteria:

  1. Contraindications to regional citrate anticoagulation.
  2. Irreversible brain damage based on available historical and clinical information.
  3. Presence of a renal transplant at any time.
  4. Non-candidacy for acute renal replacement therapy.
  5. Non-renal organ transplantation within six months of screening date.
  6. 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).
  7. 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.
  8. Metastatic malignancy which is actively being treated or may be treated by chemotherapy or radiation during the subsequent three month period after study therapy
  9. 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
  10. Severe liver failure as documented by a Child-Pugh Liver Failure Score >12.
  11. Do Not Resuscitate (DNR) status.
  12. Comfort measures only.
  13. Patient is moribund or for whom full supportive care is not indicated.
  14. Patient not expected to survive 28 days because of an irreversible medical condition.
  15. Any medical condition that the Investigator thinks may interfere with the study objectives.
  16. Physician refusal.
  17. Patient pregnant.
  18. Patient is a prisoner.
  19. Pre-morbid weight >128.5 kg.
  20. More than one hemodialysis treatment or longer than 24 hours since starting CRRT.
  21. Platelet count <30,000/mm3.
  22. 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.
  23. Use of any other Investigational drug or device within the previous 30 days.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072682

Locations
United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
United States, California
University of California San Diego
San Diego, California, United States, 92103
United States, Colorado
Denver Nephrology
Denver, Colorado, United States, 80230
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20037
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Tennessee
Memorial Hospital
Chattanooga, Tennessee, United States, 37404
United States, Texas
University of Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
CytoPherx, Inc
Harvard Clinical Research Institute
Medtox
  More Information

No publications provided

Responsible Party: CytoPherx, Inc
ClinicalTrials.gov Identifier: NCT01072682     History of Changes
Other Study ID Numbers: ARF002
Study First Received: February 17, 2010
Last Updated: August 31, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by CytoPherx, Inc:
Acute Renal Failure
Acute tubular necrosis
Continuous Renal Replacement Therapy
Selective cytopheretic device

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 20, 2014