Efficacy Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Kidney Injury
Verified January 2013 by CytoPherx, Inc
Information provided by (Responsible Party):
First received: July 21, 2011
Last updated: January 14, 2013
Last verified: January 2013
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).
Acute Kidney Injury
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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)
Primary Outcome Measures:
- The Primary Clinical Efficacy endpoint in this trial is all cause mortality through 60 days post-randomization. [ Time Frame: Day 60 following treatment end ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Renal Replacement Therapy dependency at day 60. [ Time Frame: Day 60 following treatment end ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
- Time to mortality for the Severe Septic patients through day 60 [ Time Frame: Day 60 following treatment ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
Experimental: CRRT + SCD (severe sepsis)
Patients with a diagnosis of severe sepsis will be randomized
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.
No Intervention: CRRT alone (severe sepsis)
Patients with a diagnosis of severe sepsis will be randomized
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.
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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 (proven or suspected) of severe sepsis as defined in Appendix C.
- All patients must be able to tolerate regional citrate anticoagulation.
- 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.
- 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.
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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: NCT01400893
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 21, 2011
||January 14, 2013
||United States: Food and Drug Administration
Keywords provided by CytoPherx, Inc:
Acute Renal Failure
Acute kidney injury
Acute tubular necrosis
Continuous Renal Replacement Therapy
Selective cytopheretic device
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 24, 2014
Acute Kidney Injury
Wounds and Injuries