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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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)

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 Summary: 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.
Sponsor: CytoPherx, Inc

Current 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 end ]

Original Primary Outcome: 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 ]

Current Secondary Outcome:

  • 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 ]
  • Time to mortality for the Severe Septic patients through day 60 [ Time Frame: Day 60 following treatment ]


Original Secondary Outcome:

  • 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.


Information By: CytoPherx, Inc

Dates:
Date Received: July 21, 2011
Date Started: August 2011
Date Completion:
Last Updated: September 4, 2014
Last Verified: September 2014