A prospective, randomized, multicenter study evaluating early corticosteroid withdrawal with Thymoglobulin® in living‐donor kidney transplantation

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Woodle ES, Peddi VR, Tomlanovich S, Mulgaonkar S, Kuo PC, for the TRIMS Study Investigators. A prospective, randomized, multicenter study evaluating early corticosteroid withdrawal with Thymoglobulin® in living‐donor kidney transplantation. Clin Transplant 2010: 24: 73–83. © 2009 John Wiley & Sons A/S. Abstract: Background: This study compared the safety and efficacy of early corticosteroid withdrawal (ECSWD) with rabbit anti‐thymocyte globulin (rATG) induction to chronic corticosteroid therapy (CCST) without antibody induction in primary, living‐donor renal transplant recipients. Methods: Eligible subjects were randomized 2:1 to receive either an ECSWD (n = 103) or CCST (n = 48) regimen, with all subjects receiving tacrolimus and mycophenolate mofetil (MMF). Results: Results are reported as ECSWD vs. CCST. No significant differences were observed in the primary composite endpoint of freedom from biopsy‐proven acute rejection (BPAR), graft loss, and death at six months (85.4% vs. 85.4%) or 12 months (84.4% vs. 74.4%). At 12 months, no difference was observed in BPAR (13.9% vs. 19.4%); however, ECSWD was associated with lower total cholesterol (159.7 ± 39.2 vs. 196.5 ± 56.7 mg/dL, p = 0.012), and trends toward significance were noted in serum triglycerides (151.9 ± 92.0 vs. 181.4 ± 78.8 mg/dL, p = 0.073) and weight gain (+3.6 ± 9.4 vs. +6.4 ± 9.3 kg, p = 0.069). No differences were observed in serious adverse events or infectious complications, with the exception of a higher incidence of leukopenia with ECSWD. Conclusions: rATG with tacrolimus and MMF therapy may allow early elimination of corticosteroids, is associated with trends toward lower lipid levels, less weight gain, and a safety profile comparable to CCST therapy.