A multicenter clinical study comparing event-free survival at 6 months after transplant between Thymoglobulin-treated and Simulect-treated adult kidney transplant patients. Patients received Thymoglobulin or Simulect from Day 0 through Day 4. Day 0 was considered the day of the transplant procedure. Subjects meeting all inclusion and exclusion criteria were eligible to participate in this study. The treatment assignment was random and not chosen by the subject or their physician. Subjects were monitored during treatment with Thymoglobulin and during the transplant hospitalization. Additional subject monitoring occurred up to 12 months after transplant. 278 study subjects were enrolled at 28 transplant centers in the United States and Europe.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
240
1.5 mg/kg per day, for a maximum of 5 doses
20 mg per day on 2 days
University of Alabama
Birmingham, Alabama, United States
UCLA School of Medicine
Los Angeles, California, United States
California Pacific Medical Center
San Francisco, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Florida Hospital Medical Center and Translife
Orlando, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
Rush University Transplant Program
Chicago, Illinois, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
...and 18 more locations
Freedom from acute rejection, kidney transplant loss, delayed kidney transplant function and death at 6 months after transplant.
Time frame: 6 months
12-mo. safety & efficacy assessments including side effects and overall kidney transplant function.
Time frame: 12 months
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