Efficacy and cardiovascular safety of daclizumab, mycophenolate mofetil,tacrolimus, and early steroid withdrawal in renal transplant recipients: a multicenter,prospective, pilot trial

This single-arm, open-label, pilot study was designed to assess the
efficacy and cardiovascular safety profile of daclizumab, a humanized
monoclonal interleukin (IL)-2Ra antibody, in combination with mycophenolate
mofetil (MMF), tacrolimus, and early corticosteroid withdrawal
in renal transplant recipients. Seventy-nine renal allograft recipients were
treated with daclizumab (1 mg/kg; five doses starting on the day before
transplant and then every two weeks), MMF (1 g b.i.d.), tacrolimus
(0.2 mg/kg/d), and low-dose prednisolone, which was withdrawn at day 150
after transplant. The rate of acute rejection was determined at 12 months.
Lipid profile, oral glucose tolerance, and adverse events were monitored.
Of the 76 patients eligible for analysis, eight (10.5%) developed biopsyproven
acute rejection (BPAR). Ten (13.2%) experienced clinical and/or
BPAR. Corticosteroids were withdrawn completely in 91% of patients
at 12 months. Graft and patient survival were 97.5% and 98.7%
respectively. Mean total cholesterol and triglycerides were significantly
lower at 12 months post-transplant than at baseline (201 ± 47.5 vs.
190.8 ± 43.6 mg/dL, p ¼ 0.005 and 196.2 ± 133.2 vs. 144.5 ± 76.8 mg/
dL, p < 0.001, respectively). Mean hemoglobin A1c levels did not differ
between baseline (5.54%) and 12 months (5.48%). New-onset posttransplant
diabetes mellitus occurred in 6.6% of the non-diabetic transplanted
patients. The proportion of patients with abnormal oral glucose
tolerance test (OGTT) was 47% at 3 months and 39% at 12 months
(p ¼ NS). Daclizumab induction in combination with MMF, tacrolimus,
and low-dose (followed by withdrawal) prednisolone appears to be effective
and safe in patients receiving renal allografts. The regimen appears to be
associated with a favorable cardiovascular profile.