A Multicenter, Open Label Pilot Study of Early (5 Day) Corticosteroid Cessation in De Novo Renal Transplant Recipients Under Simulect, Tacrolimus, and Sirolimus Therapy: One Year Results

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O430 Aims: New immunosuppressive regimens that allow early corticosteroid cessation (ECC) are being reported with increasing frequency. However, few prospective multicenter trials exist evaluating ECC. Herein, we report 1 year (yr) results of the first multicenter trial of ECC under tacrolimus/sirolimus based immunosuppression. Methods: This study is a single limb, open label, multicenter study conducted at 8 sites. Primary endpoints included biopsy confirmed acute rejection (AR) and the proportion of patients (pts) off CS at 6 months. Secondary endpoints included: study withdrawal, calculated GFR, serum creatinine, and pt and graft survival. Inclusion criteria included primary renal transplant (Tx) recipients aged 18 or greater. Exclusion criteria included: African American race, WBC < 3000/ul, fasting hypercholesterolemia or hypertriglyceridemia, and PRA > 50%. Immunosuppression included: Simulect (20mg on posttransplant day (PTD) 0 and 4; tacrolimus (target level 6-9 ng/ml), sirolimus (target level 8-15 ng/ml), and solumedrol (PTD 0-4; 250, 250, 125, 65, 30 mg then DC). Results: 77 pts were enrolled with 1 yr followup. Demographics included: 57% male; 79% Caucasian, 14.5% Hispanic, and 6.5% Asian. Median age at Tx was 51 yr (range 22-69). Donor source included 26% cadaver, 35% living unrelated, 39% living related. ESRD etiology included diabetes in 32.5% of pts. At one yr, pt and graft survival were both 100%; AR occurred in 13% (80% of AR occurred in first 6 mos post-Tx). Most AR were mild; Banff criteria: IA (7), IB (1), IIA (1), IIB (1). AR treatment consisted of: steroids (100%) and antilymphocyte antibody (90%). Serum creatinine at 12 mos was 1.49 +/- 0.09 mg/dL with a mean calculated GFR of 67.7 +/- 2.9 ml/min. Study withdrawal occurred in 26%: tacrolimus toxicity (2), poor wound healing (3), lack of efficacy (1), protocol violation (2),oral ulcers (2), marrow suppression (2). PostTx diabetes occurred in 14.4% of pts. PTLD, CMV, and Pneumocystis were not observed. Infections occurred in 59% of pts, with UTI and URI accounting for 60% of infections. DGF occurred in 22% of pts. Mean weight gain was 1.3 kg/pt. 79.2% of pts were off CS at 1 yr. 26% of pts required new antilipid therapy. Conclusions: This pilot analysis demonstrates excellent patient and graft survival with low rates of AR with an acceptable side effect profile. Additional comprehensive studies comparing this to conventional approaches are warranted.