Clinical Study

Comparable Renal Function at 6 Months with Tacrolimus Combined with Fixed-Dose Sirolimus or MMF: Results of a Randomized Multicenter Trial in Renal Transplantation

Table 3

Selected secondary endpoints.

Tacrolimus/Sirolimus N=318Tacrolimus/MMF N=316

Acute Rejection, Number (%)82 (25.8)77 (24.4)

Biopsy confirmed acute rejection, Number (%):48 (15.1)a39 (12.3)a
Spontaneously resolving1 (0.3)0 (0.0)
Corticosteroid sensitive34 (10.7)32 (10.1)
Corticosteroid resistant14 (4.4)8 (2.5)
 Resolved with further treatment12 (3.8)8 (2.5)
Other1 (0.3)0 (0.0)

Histological grade, Number (%):
 Mild (Banff I)30 (9.4)20 (6.3)
 Moderate (Banff II)17 (5.3)17 (5.4)
 Severe (Banff III)1 (0.3)2 (0.6)

Patient survivalb, %99.099.0

Graft survivalb, %92.793.3

FAS
Morea than one BCAR episode was reported for some patients.
Kaplanb-Meier estimates.