"A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation"
"A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation"
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).
Inclusion Criteria:

 -  primary renal transplant (not HLA identical)

 -  ages 18-60 years

 Exclusion Criteria:

 -  recipient panel reactive antibody level >10%

 -  recipient of a DCD kidney

 -  no prior organ transplant

 -  no multi-organ transplant recipient

 -  no subject who is currently receiving systemic corticosteroids

 -  no pregnant or lactating subjects

 -  no history of Hepatitis B, C or HIV positivity

 -  no recipient of a kidney with cold ischemia time >36 hours