Once-Daily versus Twice-Daily Tacrolimus in Living Kidney Transplantation: A Multicenter, Parallel Group, Open-Label, 5-Year, Randomized Non-Inferiority Trial.
1Nephrology, Tokyo Women's Medical University, Tokyo, Japan
2Urology, Tokyo Women's Medical University, Tokyo, Japan
3Urology, Tokyo Women's Medical University Yachiyo Medical Center, Yachiyo, Japan
4Urology, Ohkubo Hospital, Tokyo, Japan
5Transplant Surgery, Toda Chuo General Hospital, Toda, Japan
Meeting: 2017 American Transplant Congress
Abstract number: D92
Keywords: Area-under-curve (AUC), Calcineurin, Immunosuppression, Kidney transplantation
Session Information
Session Name: Poster Session D: Kidney Immunosuppression: Novel Regimens and Drug Minimization
Session Type: Poster Session
Date: Tuesday, May 2, 2017
Session Time: 6:00pm-7:00pm
Presentation Time: 6:00pm-7:00pm
Location: Hall D1
Background:
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) .
Results:
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).
Conclusions:
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 May 9, 2025.« Back to 2017 American Transplant Congress