Safety and efficacy study of SANGUINATE on reduction of delayed graft function (DGF) in patients who will be recipients of a donation after brain death (DBD) donor kidney.
Phase 2: Sixty (60) adult subjects who will be recipients of a donation after brain death (DBD) donor kidney and who meet all eligibility criteria will be randomized 1:1 within 48 hours prior to transplant surgery to receive: two infusions of SANGUINATE at a dose of 320 mg/kg or placebo on the day of surgery and approximately 24 hours after surgery. Patients will be hospitalized for up to 5 days and the study duration will be 30 days. Results will be used to inform the study design characteristics for Phase III, including sample size. Phase III: The same inclusion/exclusion requirements, dosing schedule, hospitalization stay and outpatient visits as in Phase II with additional visits scheduled at Day 90, Day 180 and Day 365. Study duration will be 365 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Two (2) infusions of 320 mg/kg of SANGUINATE at Baseline and Day 1
Two (2) infusions of Normal Saline at an equal volume to SANGUINATE at Baseline and Day 1.
Mayo Clinic Phoenix
Phoenix, Arizona, United States
Reduction of delayed graft function (DGF)
Reduction of delayed draft function will be measured by the number of dialysis sessions.
Time frame: 30 Days
Participants With at Least One Occurrence of Safety Composite Endpoint by Treatment Group
Composite endpoint defined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis, graft loss, death and other reported adverse events
Time frame: Phase 2 - 30 Days; Phase 3: Safety - 90 days; Serious Adverse Events and Adverse Events of Special Interest - 180 Days; Graft Survival - 365 Days
Proportion of subjects requiring dialysis for any reason in the first 7 days post-transplant
Time frame: 7 Days
Proportion of subjects requiring dialysis only in the first 5 days post-transplant
Time frame: 5 Days
Number of days of dialysis therapy.
Time frame: 30 Days
Proportion of subjects with a fall in serum creatinine.
Time frame: 7 Days
Proportion of subjects with a serum creatinine greater than 3 mg/dL, but who did not require dialysis by Day 5 post-transplant
Time frame: 5 Days
Rate of change in estimated creatinine clearance and estimated glomerular filtration rate over time
Time frame: Phase 2: 30 Days
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University of California, Los Angeles
Los Angeles, California, United States
California Institute of Renal Research
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
University of California San Francisco
San Francisco, California, United States
Medstar Georgetown University Hosiptal
Washington D.C., District of Columbia, United States
Tampa General Hospital
Tampa, Florida, United States
Augusta University
Augusta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
UIC University of Illinois at Chicago
Chicago, Illinois, United States
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