The purpose of the study is to see if campath-1H can be used in first time renal transplant subjects to prevent rejection and reduce the overall amount of anti-rejection medications that patients take on a daily basis.
Twenty nine primary recipients of either a live donor or deceased donor renal transplant were enrolled in this study. Subjects were administered two 20mg doses of Campath-1H antibody therapy (Day 0 and Day 1) in combination with a short course of corticosteroids, and maintenance sirolimus. Subjects were followed for 3 years to compare the incidence and severity of rejection episodes, complications related to the immunosuppression, including infections, malignancies and adverse events. All subjects underwent protocol renal transplant biopsies at 6 and 12 months (unless medically contraindicated).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
29
University of Wisconsin
Madison, Wisconsin, United States
Incidence of Allograft Rejection
Time frame: 3 years
Incidence of Severe Allograft Rejection ( Defined as >Banff 2A or Requiring Antibody Treatment)
Time frame: 3 years
Patient Survival
Time frame: 3 years
Incidence of Post-transplant Infection
Event of post-transplant infection (more than one "event" might have been counted per participant)
Time frame: 3 years
Incidence of Malignancies
Number of Participants Experiencing Malignancies
Time frame: 3 years
Kidney Allograft Survival
Time frame: 3 years
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