Date: Saturday, June 11, 2016
Session Name: Poster Session A: Kidney: Acute Cellular Rejection
Session Time: 5:30pm-7:30pm
Presentation Time: 5:30pm-7:30pm
Location: Halls C&D
Introduction. The aim of the study was to determine the efficacy and safety balance of 2 different doses of tacrolimus extended-release (TacER) in kidney transplant recipients between 4 and 12 months post-transplantation. Methods. This clinical trial (NCT01744470) compared non-immunized stable patients randomized 4 months after in two groups (1:1): Group A : 50 % reduction of the daily dose of TacER and with targeted Tacrolimus trough level (TacC0) > 3 [micro]g/L ; Group B : continuation of the pre randomization dose and targeted TacC0 between 7 and 12 [micro]g/L. Primary Outcome was renal function (GFR estimated by MDRD) at 1 year. Secondary end points included the assessment of 1-year efficacy and safety data. Results. Among 300 patients included between 10/2012 and 06/2014, 188 were randomized (group A: 89, group B: 99). TacC0 were lower in group A than in group B at 6 (4.1±2.7 vs 6.7±3.9[micro]g/L, p<0.0001) and 12 months (5.6±2.0 vs 7.4±2.1[micro]g/L, p<0.0001). Renal function was similar in both groups at 4, 6 and 12 months. Patients with reduced TacER daily doses experienced more acute cellular rejection episodes between month 4 and 12 (log rank, p=0.047). In addition, interstitial infiltrate was more frequently observed at 12 months in group A than in group B (21.4 vs 8.8%, p=0.047). Of note, IF/TA and chronic vascular lesions were similar in both groups. De novo DSA were found only in reduced dose group (6 patients vs. 0). BK virus viremia and CMV infection rates were similar in both groups. Conclusion Reduced daily dose and TacC0 during the first year post-transplantation impaired the efficacy of immunosuppressive regimen based on TacER in low immunologic risk kidney transplant patients.
CITATION INFORMATION: Gatault P, Kamar N, Buchler M, Colosio C, Bertrand D, Durrbach A, Albano L, Rivalan J, Essig M, Le Meur Y, Bouvier N, Charpentier B, Thervet E, Rostaing L, Lebranchu Y. Comparison of Efficacy and Safety of a 4-Month Post-Renal Transplant Dose Reduction of Tacrolimus. Am J Transplant. 2016;16 (suppl 3).
To cite this abstract in AMA style:Gatault P, Kamar N, Buchler M, Colosio C, Bertrand D, Durrbach A, Albano L, Rivalan J, Essig M, Meur YLe, Bouvier N, Charpentier B, Thervet E, Rostaing L, Lebranchu Y. Comparison of Efficacy and Safety of a 4-Month Post-Renal Transplant Dose Reduction of Tacrolimus. [abstract]. Am J Transplant. 2016; 16 (suppl 3). https://atcmeetingabstracts.com/abstract/comparison-of-efficacy-and-safety-of-a-4-month-post-renal-transplant-dose-reduction-of-tacrolimus/. Accessed January 24, 2021.
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