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See detailSuperior Renal Function Sustained for 24 Months through Early Everolimus-Facilitated Reduction of Tacrolimus Versus Standard Tacrolimus in De Novo Liver Transplant Recipients: Results of a Randomized Trial.
De Simone, Pierre; DETRY, Olivier ULg; Kintmalm, G et al

in American Journal of Transplantation (2013, April), 13(S5), 169450

mTOR inhibitors have the potential to reduce calcineurin inhibitor nephrotoxicity by minimizing or eliminating the need for their use. The 12 month (M) results of H2304 (NCT00622869) study demonstrated ... [more ▼]

mTOR inhibitors have the potential to reduce calcineurin inhibitor nephrotoxicity by minimizing or eliminating the need for their use. The 12 month (M) results of H2304 (NCT00622869) study demonstrated superior renal function with everolimus (EVR) plus reduced tacrolimus (rTAC) vs. standard TAC (TAC-C) in de novo liver transplant recipients (LTxR). Presented here are 24M renal function results. For this 24M, multicenter, open-label study 719 de novo LTxR were randomized (1:1:1) after a 30-day (±5 days) run-in period with TAC (±mycophenolate mofetil), to receive either EVR (C0 3-8 ng/mL) with rTAC (C0 3-5 ng/mL; EVR+rTAC, N=245) or EVR (C0 6-10 ng/mL) with TAC withdrawal (TAC-WD; N=231) at M4 or TAC-C (C0 6-10 ng/mL; TAC-C, N=243); all patients received corticosteroids. Enrollment in TAC-WD arm was stopped early due to higher rejection rates. Main endpoints at M24 included composite ef􏰀cacy failure rate of treated biopsy proven acute rejection, graft loss or death, and evolution of renal function from randomization (RND) to M24 measured as eGFR by MDRD4. At M24, composite ef􏰀cacy failure rate in EVR+rTAC arm was comparable to TAC-C (10.3% vs. 12.5%, p=0.452). Evolution of renal function from RND to M24 was superior for EVR+rTAC vs. TAC-C with an adjusted mean difference in eGFR change of 6.66 mL/min/1.73m2 (p=0.0018; ITT population). Signi􏰀cantly higher eGFR with EVR+rTAC was achieved at M2 post-LTx and was maintained until M24. On-treatment data showed a decrease in mean eGFR from RND to M24 of 6.6 mL/min/1.73m2 with EVR+rTAC vs. 13 mL/min/1.73m2 with TAC-C and 2.5 mL/ min/1.73m2 gain with TAC-WD. Urinary protein:creatinine ratio (mg/g) at M24 was higher with EVR+rTAC vs. TAC-C (Mean±SD: 194±280 vs. 159±284, p=0.006). Early introduction of EVR at 1M post-LTx with rTAC showed superior renal function sustained for 24M compared to TAC-C, without compromising ef􏰀cacy in de novo LTxR. [less ▲]

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See detailEfficacy and safety of maribavir dosed at 100 mg orally twice daily for the prevention of cytomegalovirus disease in liver transplant recipients: a randomized, double-blind, multicenter controlled trial.
Winston, D. J.; Saliba, F.; Blumberg, E. et al

in American Journal of Transplantation (2012), 12(11), 3021-30

Maribavir is an oral benzimidazole riboside with potent in vitro activity against cytomegalovirus (CMV), including some CMV strains resistant to ganciclovir. In a randomized, double-blind, multicenter ... [more ▼]

Maribavir is an oral benzimidazole riboside with potent in vitro activity against cytomegalovirus (CMV), including some CMV strains resistant to ganciclovir. In a randomized, double-blind, multicenter trial, the efficacy and safety of prophylactic oral maribavir (100 mg twice daily) for prevention of CMV disease were compared with oral ganciclovir (1000 mg three times daily) in 303 CMV-seronegative liver transplant recipients with CMV-seropositive donors (147 maribavir; 156 ganciclovir). Patients received study drug for up to 14 weeks and were monitored for CMV infection by blood surveillance tests and also for the development of CMV disease. The primary endpoint was Endpoint Committee (EC)-confirmed CMV disease within 6 months of transplantation. In a modified intent-to-treat analysis, the noninferiority of maribavir compared to oral ganciclovir for prevention of CMV disease was not established (12% with maribavir vs. 8% with ganciclovir: event rate difference of 0.041; 95% CI: -0.038, 0.119). Furthermore, significantly fewer ganciclovir patients had EC-confirmed CMV disease or CMV infection by pp65 antigenemia or CMV DNA PCR compared to maribavir patients at both 100 days (20% vs. 60%; p < 0.0001) and at 6 months (53% vs. 72%; p = 0.0053) after transplantation. Graft rejection, patient survival, and non-CMV infections were similar for maribavir and ganciclovir patients. Maribavir was well-tolerated and associated with fewer hematological adverse events than oral ganciclovir. At a dose of 100 mg twice daily, maribavir is safe but not adequate for prevention of CMV disease in liver transplant recipients at high risk for CMV disease. [less ▲]

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See detailThe prognostic value of renal resistance during hypothermic machine perfusion of deceased donor kidneys
Jochmans, I.; Moers, C.; Smits, J. M. et al

in American Journal of Transplantation (2011), 11

Vascular renal resistance (RR) during hypothermic machine perfusion (HMP) is frequently used in kidney graft quality assessment. However, the association between RR and outcome has never been ... [more ▼]

Vascular renal resistance (RR) during hypothermic machine perfusion (HMP) is frequently used in kidney graft quality assessment. However, the association between RR and outcome has never been prospectively validated. Prospectively collected RR values of 302 machine-perfused deceased donor kidneys of all types (standard and extended criteria donor kidneys and kidneys donated after cardiac death), transplanted without prior knowledge of these RR values, were studied. In this cohort, we determined the association between RR and delayed graft function (DGF) and 1-year graft survival. The RR (mmHg/mL/min) at the end of HMP was an independent risk factor for DGF (odds ratio 21.12 [1.03–435.0]; p = 0.048) but the predictive value of RR was low, reflected by a c-statistic of the receiver operator characteristic curve of 0.58. The RR was also found to be an independent risk factor for 1-year graft failure (hazard ratio 12.33 [1.11–136.85]; p = 0.004). Determinants of transplant outcome are multifactorial in nature and this study identifies RR as an additional parameter to take into account when evaluating graft quality and estimating the likelihood of successful outcome. However, RR as a stand-alone quality assessment tool cannot be used to predict outcome with sufficient precision. [less ▲]

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See detailAllocation of ECD Kidneys Based on Donor GFR: The Choice of the Estimating Equation Matters
Delanaye, Pierre ULg; Rozet, Eric ULg; Maillard, N. et al

in American Journal of Transplantation (2010), 10(6), 1493-1494

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See detailDelayed introduction of reduced-dose tacrolimus, and renal function in liver transplantation: the 'ReSpECT' study
Neuberger, J. M.; Mamelok, R. D.; Neuhaus, P. et al

in American Journal of Transplantation (2009), 9(2), 327-336

We report a multicenter, prospective, randomized, open-label trial investigating the effect of lower levels and delayed introduction of tacrolimus on renal function in liver transplant recipients. Adult ... [more ▼]

We report a multicenter, prospective, randomized, open-label trial investigating the effect of lower levels and delayed introduction of tacrolimus on renal function in liver transplant recipients. Adult patients with good renal function undergoing primary liver transplant were randomized to either: group A (standard-dose tacrolimus [target trough levels >10 ng/mL] and corticosteroids; n = 183); group B (mycophenolate mofetil [MMF] 2g/day, reduced-dose tacrolimus [target trough levels </=8 ng/mL], and corticosteroids; n = 170); group C (daclizumab induction, MMF, reduced-dose tacrolimus delayed until the fifth day posttransplant and corticosteroids, n = 172). The primary endpoint was change from baseline in estimated glomerular filtration rate (eGFR) at 52 weeks. The eGFR decreased by 23.61, 21.22 and 13.63 mL/min in groups A, B and C, respectively (A vs C, p = 0.012; A vs B, p = 0.199). Renal dialysis was required less frequently in group C versus group A (4.2% vs. 9.9%; p = 0.037). Biopsy-proven acute rejection rates were 27.6%, 29.2% and 19.0%, respectively. Patient and graft survival was similar. In conclusion, daclizumab induction, MMF, corticosteroids and delayed reduced-dose tacrolimus was associated with less nephrotoxicity than therapy with standard-dose tacrolimus and corticosteroids without compromising efficacy or tolerability. [less ▲]

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See detailPharmacokinetics for once- versus twice-daily tacrolimus formulations in de novo kidney transplantation: a randomized, open-label trial.
Wlodarczyk, Z.; Squifflet, Jean-Paul ULg; Ostrowski, M. et al

in American Journal of Transplantation (2009), 9(11), 2505-13

Tacrolimus, a cornerstone immunosuppressant, is widely available as a twice-daily formulation (Tacrolimus BID). A once-daily prolonged-release formulation (Tacrolimus QD) has been developed that may ... [more ▼]

Tacrolimus, a cornerstone immunosuppressant, is widely available as a twice-daily formulation (Tacrolimus BID). A once-daily prolonged-release formulation (Tacrolimus QD) has been developed that may improve adherence and impart long-lasting graft protection. This study compared the pharmacokinetics (PK) of tacrolimus in de novo kidney transplant patients treated with Tacrolimus QD or Tacrolimus BID. A 6-week, open-label, randomized comparative study was conducted in centers in Europe and Australia. Eligible patients received Tacrolimus QD or Tacrolimus BID. PK profiles were obtained following the first tacrolimus dose (day 1), and twice under steady-state conditions. As secondary objectives, efficacy and safety parameters were also evaluated. Sixty-six patients completed all PK profiles (34 Tacrolimus QD, 32 Tacrolimus BID). Mean AUC(0-24) of tacrolimus on day 1 was approximately 30% lower for Tacrolimus QD than Tacrolimus BID (232 and 361 ng.h/mL, respectively), but was comparable by day 4. There was a good correlation and a similar relationship between AUC(0-24) and C(min) for both formulations. Efficacy and safety data were also comparable over the 6-week period. Tacrolimus QD can be administered once daily in the morning on the basis of the same systemic exposure and therapeutic drug monitoring concept as Tacrolimus BID. [less ▲]

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See detailTransmission of lymphoma via organ transplantation
Detry, Olivier ULg

in American Journal of Transplantation (2008), 8

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See detailCholestatic syndrome after liver transplantation. Prognosis and risk factors
De Roover, Arnaud ULg; Meurisse, Nicolas ULg; Marival, Talia et al

in American Journal of Transplantation (2005, May), 5(Suppl. 11), 205

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See detailTransplantation of a liver graft from a living donor with early gastric cancer
Detry, Olivier ULg; De Roover, Arnaud ULg; Honore, Pierre ULg et al

in American Journal of Transplantation (2005), 5(9), 2331-2332

Detailed reference viewed: 23 (17 ULg)