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.
RCT Entities:
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.
Authors: Bekir Tanriover; Song Zhang; Malcolm MacConmara; Ang Gao; Burhaneddin Sandikci; Mehmet U S Ayvaci; Mutlu Mete; Demetra Tsapepas; Nilum Rajora; Prince Mohan; Ronak Lakhia; Christopher Y Lu; Miguel Vazquez Journal: Clin J Am Soc Nephrol Date: 2015-05-15 Impact factor: 8.237
Authors: L E Nikkel; S Mohan; A Zhang; D J McMahon; S Boutroy; G Dube; B Tanriover; D Cohen; L Ratner; C S Hollenbeak; M B Leonard; E Shane; T L Nickolas Journal: Am J Transplant Date: 2011-12-07 Impact factor: 8.086
Authors: Bekir Tanriover; Vishal Jaikaransingh; Malcolm P MacConmara; Justin R Parekh; Swee-Ling Levea; Venkatesh K Ariyamuthu; Song Zhang; Ang Gao; Mehmet U S Ayvaci; Burhaneddin Sandikci; Nilum Rajora; Vaqar Ahmed; Christopher Y Lu; Sumit Mohan; Miguel A Vazquez Journal: Clin J Am Soc Nephrol Date: 2016-06-30 Impact factor: 8.237
Authors: William A Werbel; Sunjae Bae; Sile Yu; Fawaz Al Ammary; Dorry L Segev; Christine M Durand Journal: Am J Transplant Date: 2020-08-13 Impact factor: 8.086
Authors: Andreas Zuckermann; Uwe Schulz; Tobias Deuse; Arjang Ruhpawar; Jan D Schmitto; Andres Beiras-Fernandez; Stephan Hirt; Martin Schweiger; Laurenz Kopp-Fernandes; Markus J Barten Journal: Transpl Int Date: 2014-11-11 Impact factor: 3.782