The objective of the study is to evaluate the safety and activity of a investigational drug in improving renal function in patients who have undergone renal transplantation and have signs and symptoms of significant renal injury and are at risk for dialysis.
Delayed graft function (DGF) is generally defined as the need for dialysis during the first 7 days after transplantation although the definition can also include failure to improve preexisting renal function. DGF is an important problem in renal allograft transplantation that affects approximately 25% of transplanted cadaveric kidneys. It has generally been observed that delayed graft function has been associated with reduced graft survival. In addition to an association of DGF with graft loss, DGF imposes an economic burden due to prolonged hospitalization and dialysis. The strongest association with occurrence of DGF is ischemia around the time of transplantation. Aside from approaches to minimize ischemia time and use of antibody induction, there are no good specific therapeutic options to prevent or treat delayed graft function. This study is designed to evaluate the safety and activity of an investigational drug in improving renal function in patients who have undergone renal transplantation and have signs and symptoms of significant renal injury and are at risk for dialysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
intravenous drug
California Institute of Renal Research
San Diego, California, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Division of Transplant Surgery, University of Maryland School of Medicine, University of Maryland Medical Center
Urine production
mean time (days) until production of ≥ 50 cc/H of urine over a 12 hour period
Time frame: 28 days
Change from baseline urine production
Change from baseline urine production (cc/H) at each of the following time points: Day 3, Day 7, Day 14, and Day 28
Time frame: 28 days
creatinine clearance
Mean measured 24-hour creatinine clearance at Days 3, 7, 14, and 28
Time frame: 28 days
Incidence of delayed graft function
Incidence of delayed graft function (required dialysis due to inadequate renal function during the 7 days after transplantation)
Time frame: 7 days
Number of dialysis sessions
Number of dialysis sessions through Day 7, 14, and 28
Time frame: 28 days
Daily urine output
Mean total daily urine output through Day 14
Time frame: 14 days
Mean serum creatinine
Mean serum creatinine at Days 4, 7, 10, 14, and 28
Time frame: 28 days
Number of acute rejection episodes
Number of acute rejection episodes
Time frame: 28 days
Length of hospitalization following transplantation
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Baltimore, Maryland, United States
State University of New York at Buffalo
Buffalo, New York, United States
The Methodist Hospital
Houston, Texas, United States
Length of hospitalization following transplantation
Time frame: 28 days
Biomarkers
Comparison of biomarkers
Time frame: 28 days
adverse events, clinical laboratory evaluations, vital signs, ECG results
Safety assessments include adverse events, clinical laboratory evaluations, vital signs, ECG results.
Time frame: 28 days