"A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation
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).
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Incidence of Allograft Rejection
Stuart J Knechtle
University of Wisconsin, Madison
United States: Food and Drug Administration
|University of Wisconsin||Madison,, Wisconsin 53792-5666|