Over the 5 year period from 7/14/1989 until 5/24/1994, we have attempt
ed graft salvage with tacrolimus conversion in a total of 169 patients
(median age 33 years, range 2-75 years) with ongoing rejection on bas
eline CsA immunosuppression after failure of high dose corticosteroids
and/or antilymphocyte preparations to reverse rejection. The indicati
ons for conversion to tacrolimus were ongoing, biopsy confirmed reject
ion in all patients. The median interval to tacrolimus conversion was
2 months (range 2 days to 55 months; mean 4.3+/-2.6 months) after tran
splantation. All patients had failed high dose corticosteroid therapy
and 144 (85%) of the 169 patients had received at least one course of
an antilymphocyte preparation plus high dose corticosteroid therapy pr
ior to conversion. Twenty-eight patients (17%) were dialysis-dependent
at the time of conversion owing to the severity of rejection. With a
mean follow-up of 30.0+/-2.4 months (median 36.5 months, range 12-62 m
onths), 125 of 169 patients (74%) have been successfully rescued and s
till have functioning grafts with a mean serum creatinine (SCR) of 2.3
+/-1.1 mg/dl. Of the 144 patients previously treated with antilymphocy
te preparations, 117 (81%) were salvaged. Of the 28 patients on dialys
is at the time of conversion to tacrolimus, 13 (46%) continue to have
functioning grafts (mean SCR 2.15+/-0.37 mg/dl) at a mean follow-up of
37.3 +/- 16.7 months. In the 125 patients salvaged, prednisone doses
have been lowered from 28.0+/-9.0 mg/d (median 32, range 4-60 mg/d) pr
econversion to 8.5+/-4.1 mg/d (median 12 mg/d, range 2.5-20 mg/d) post
conversion. Twenty-eight patients (22.4%) are currently receiving no s
teroids. This 5 year experience demonstrates that tacrolimus has susta
ined efficacy as a rescue agent for ongoing renal. allograft rejection
. Based on these data, we recommend that tacrolimus be used as an alte
rnative to the conventional drugs used for antirejection therapy in re
nal transplantation.