Clinical Trial: A Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Cardiac Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2b, Randomized, Double-Blind,Placebo-Controlled, Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subj

Brief Summary: This study will evaluate the safety and efficacy of ABT-719 in preventing acute kidney injury in patients undergoing high risk cardiac surgery.

Detailed Summary:
Sponsor: AbbVie

Current Primary Outcome: Number of patients developing acute kidney injury based on the Acute Kidney Injury Network (AKIN) scoring criteria by comparing the ABT-719 dose groups versus placebo group. [ Time Frame: Up through Day 7 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of subjects developing at least one of the composite events: death, needing renal replacement therapy, or having greater than or equal to 25 percent reduction in estimated glomerular filtration rate or measured glomerular filtration rate [ Time Frame: Up through Day 90 ]
  • Proportion of subjects developing at least one of the composite events: death, needing renal replacement therapy, or having greater than or equal to 25 percent reduction in serum creatinine based estimated glomerular filtration rate (GFR) [ Time Frame: Up through Day 60 ]
  • Proportion of subjects developing AKI as defined by the Risk, Injury, Failure, Loss, or ESRD (RIFLE) model [ Time Frame: Up through Day 7 ]
  • Proportion of subjects developing AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) model [ Time Frame: Up through Day 7 ]
  • Changes from baseline (defined as within 24 hours of day 0) in serum creatinine (SCr) and S-Cystatin C at all study visits from baseline to Day 90 [ Time Frame: Up through Day 90 ]


Original Secondary Outcome: Same as current

Information By: AbbVie

Dates:
Date Received: January 24, 2013
Date Started: February 2013
Date Completion:
Last Updated: March 30, 2015
Last Verified: March 2015