A prospective, randomized, multicenter study evaluating early corticosteroid withdrawal with Thymoglobulin in living-donor kidney transplantation.
Author(s): Woodle ES, Peddi VR, Tomlanovich S, Mulgaonkar S, Kuo PC, TRIMS Study Investigators
Affiliation(s): Division of Transplantation, Department of Surgery, University of Cincinnati, Cincinnati, OH, USA. firstname.lastname@example.org
Publication date & source: 2010-01, Clin Transplant., 24(1):73-83. Epub 2009 Nov 20.
Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
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.