Date: Tuesday, May 2, 2017
Session Time: 6:00pm-7:00pm
Presentation Time: 6:00pm-7:00pm
Location: Hall D1
Tacrolimus (TAC)-based induction therapy appears to be the standard immunosuppressive regimen for most kidney transplantation recipients (KTRs). TAC is available as a twice-daily (TAC-BID) and once-daily (QD) formulation. We conducted a 5-year, long-term, multicenter, parallel group, open-label, randomized trial to determine whether TAC-QD would be noninferior to BID with respect to clinical outcomes among de novo living KTRs.
Study design and population:
A total of 130 transplant candidates were randomly assigned to either of two treatment groups.
KTRs were treated with combination immunosuppressive regimens (TAC-QD or BID, mycophenolate mofetil, methylprednisolone, and basiliximab) .
For TAC exposure-control, similar levels were maintained between groups (P=0.448), except during the pretransplant and immediate posttransplant period . Between-group coefficients of variation were similar, and decreased over time.
In intention-to-treat analysis, the 5-year cumulative graft failure rates were 6.5% (95% CI: 0.3 to 12.6) and 9.5% (95% CI: 2.3 to 16.8) in TAC-QD and BID groups, respectively . TAC-QD was not inferior to BID (noninferiority test: P=0.008). TAC-QD was not also inferior to BID regarding rate of biopsy-proven acute rejection, serum creatinine or estimated glomerular filtration rate (noninferiority test: p=0.008, P<0.001, p<0.001).
TAC-QD showed conclusive noninferiority in adverse event rates.
CITATION INFORMATION: Unagami K, Okumi M, Hirai T, Toki D, Shirakawa H, Shimizu T, Omoto K, Inui M, Ishida H, Nitta K, Tanabe K. Once-Daily versus Twice-Daily Tacrolimus in Living Kidney Transplantation: A Multicenter, Parallel Group, Open-Label, 5-Year, Randomized Non-Inferiority Trial. Am J Transplant. 2017;17 (suppl 3).
To cite this abstract in AMA style:Unagami K, Okumi M, Hirai T, Toki D, Shirakawa H, Shimizu T, Omoto K, Inui M, Ishida H, Nitta K, Tanabe K. Once-Daily versus Twice-Daily Tacrolimus in Living Kidney Transplantation: A Multicenter, Parallel Group, Open-Label, 5-Year, Randomized Non-Inferiority Trial. [abstract]. Am J Transplant. 2017; 17 (suppl 3). https://atcmeetingabstracts.com/abstract/once-daily-versus-twice-daily-tacrolimus-in-living-kidney-transplantation-a-multicenter-parallel-group-open-label-5-year-randomized-non-inferiority-trial/. Accessed January 23, 2020.
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