Tacrolimus was used as the primary immunosuppressive agent in 69 pedia
tric renal transplantations between December 17, 1989, and June 30, 19
95. Children undergoing concomitant or prior liver and/or intestinal t
ransplantation were excluded from analysis. The mean recipient age was
10.3+/-5.0 years (range, 0.7-17.5 years), Seventeen (24.6%) children
were undergoing retransplantation, and six (8.7%) had a panel reactive
antibody level of 40% or higher. Thirty-nine (57%) cases were with ca
daveric kidneys, and 30 (43%) were with living donors, The mean donor
age was 28.0+/-14.7 years (range, 1.0-50.0 years), and the mean cold i
schemia time for the cadaveric kidneys was 27.0+/-9.4 hr. The antigen
match was 2.7+/-1.2, and the mismatch was 3.1+/-1.2. All patients rece
ived tacrolimus and steroids, without antibody induction, and 26% rece
ived azathioprine as well, The mean follow-up was 32+/-20 months. One-
and 4-year actuarial patient survival rates were 100% and 95%. One- a
nd 4-year actuarial graft survival rates were 99% and 85%. The mean se
rum creatinine level was 1.2+/-0.8 mg/dl, and the calculated creatinin
e clearance was 82+/-26 ml/min/1.73 m(2). The mean tacrolimus dose was
0.22+/-0.14 mg/kg/day, and the level was 9.5+/-4.8 ng/ml. The mean pr
ednisone dose was 2.1+/-4.9 mg/day (0.07+/-0.17 mg/kg/day), and 73% of
successfully transplanted children were off prednisone, Seventy-nine
percent were not taking any antihypertensive medications. The mean ser
um cholesterol level was 158+/-54 mg/dl, The incidence of delayed graf
t function was 4.3%. The incidence of rejection was 49%, and the incid
ence of steroid-resistant rejection was 6%. The incidence of rejection
decreased to 27% in the most recent 26 cases (January 1994 through Ju
ne 1995), The incidence of new-onset diabetes was 10.1%; six of the se
ven affected children were able to be weaned off insulin. The incidenc
e of cytomegalovirus disease was 13%, and that of posttransplant lymph
oproliferative disorder was 10%; the incidence of posttransplant lymph
oproliferative disorder in the last 40 transplants was 5% (two cases),
All of the children who developed posttransplant lymphoproliferative
disorder are alive and have functioning allografts, Based on this data
, we believe that tacrolimus is a superior immunosuppressive agent in
pediatric renal transplant patients, with excellent short- and medium-
term patient and graft survival, an ability to withdraw steroids in th
e majority of patients, and, with more experience, a decreasing rate o
f rejection and viral complications.