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.