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

Authors


  • 1

    TRIMS Study Investigators and Participating Centers: Mt. Sinai School of Medicine: Enver Akalin, MD; St. Barnabas Medical Center: Shamkant Mulgaonkar, MD; Johns Hopkins University Hospital: Matthew Cooper, MD; Medical College of Virginia: Adrian H. Cotterell, MD; Indiana University: William Goggins, MD; Froedert Memorial Lutheran Hospital: Christopher Johnson, MD; Duke University: Paul C. Kuo, MD; Emory University: Christian Larsen, MD, D Phil; Ochsner Medical Center: George Loss, MD; Keck USC School of Medicine: Rod Mateo, MD; California Pacific Medical Center: V. Ram Peddi, MD; UCSF Kidney Transplant: Stephen Tomlanovich, MD; University of California Los Angles: Alan Wilkinson, MD; University of Colorado: Alexander Wiseman, MD; University of Cincinnati: E. Steve Woodle, MD; Christ Hospital: E. Steve Woodle, MD; Texas Transplant Inst.: Francis Wright, MD.

Corresponding author: E. Steve Woodle, MD, Division of Transplantation, Department of Surgery, University of Cincinnati, 231 Albert Sabin Way, PO Box 670558, Cincinnati, OH 45267, USA. Tel.: 513 558 6001; fax: 513 558 7040; e-mail: woodlees@uc.edu

Abstract

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.

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