The present study evaluated whether the addition of sirolimus to a cyclospo
rine (CyA)/prednisone (Pred) regimen mitigated the greater proclivity to ac
ute rejection episodes and graft loss characteristic of African-American re
nal transplant recipients. Using Kaplan-Meier and log-rank tests, African-A
merican renal transplant recipients treated with either CyA/Pred (n = 90) o
r sirolimus/CyA/Pred (n = 47) were compared with 120 Caucasian patients tre
ated with sirolimus/CyA/Pred for 2-year rates of patient and graft survival
as well as acute rejection episodes. Mean laboratory values were compared
using analysis of variance and F-tests. Addition of sirolimus to the CyA/Pr
ed regimen reduced the incidence of acute rejection episodes in African-Ame
ricans from 43.3 % to 19.2 % (P = 0.004), a value similar to Caucasian pati
ents. The 97.9 % 2-year graft survival rate among 47 African-American patie
nts treated with sirolimus/CyA/Pred was significantly higher than the 85.6
% rate shown among the 90 CyA/Pred-treated African-American transplant reci
pients (P = 0.0479) and similar to that in Caucasians. The 95.7 % patient s
urvival rate among the African-American sirolimus/CyA/Pred group was simila
r to the 97.8 % rate in the African-American CyA/Pred cohort. Interestingly
, there was no evident toxicity from the addition of sirolimus. The additio
n of sirolimus to a CyA-based regimen reduced acute rejection episodes and
graft loss experienced by African-American renal transplant recipients.