Date: Tuesday, May 2, 2017
Session Time: 6:00pm-7:00pm
Presentation Time: 6:00pm-7:00pm
Location: Hall D1
Purpose: Once-daily tacrolimus extended-release formulation (TACER) has now been widely accepted in kidney transplant field. However, the optimal dosage for TACER is still not known.
Patients and Methods: In this multi-center, randomized controlled trial, 62 living-donor kidney transplant recipients were assigned to 2 groups; low-dose (LD) group (n=32): target tacrolimus level for estimated area under curve (eAUC) 0-24 was set for 250ng[bull]hr/ml during the first 1 months, then reduced to 200ng[bull]hr/ml 3 months after transplantation, and very low-dose (VLD) group (n=30): initial target eAUC0-24 was 200ng[bull]hr/ml and 150ng[bull]hr/ml thereafter. All patients received basiliximab induction, mycophenolate mofetil (MMF) and corticosteroid. MMF was started with 1250mg BID and reduced to 750mg BID at 2 weeks after transplant, and adjusted to achieve eAUC0-12 at 30-60[mu]g[bull]hr/L. The primary outcomes were acute rejection, graft/patient survivals, and cytomegalovirus (CMV) infection.
Results: One-year graft and patient survival rates were 100% in both groups, and acute rejections were 0% in LD group and 10.0% in VLD group (p=0.11). Mean estimated glomerular filtration rates at 1 year were similar among the two groups (LD: 50.9±13.3ml/min/1.73m2 and VLD: 51.6±12.6ml/min/1.73m2, p=0.81). The incidences of CMV infection were lower in VLD group (LD 12.5% and VLD 6.7%, p=0.37). Calcineurin inhibitor toxicity found on protocol biopsy was observed more in VLD group at 1 month, but similar at 1 year (1 month: LD 6.3% vs VLD 17.2%, p=0.17; 1 year: LD 10.0% vs VLD 11.5%, p=0.59). Actual mean tacrolimus trough and eAUC0-24 levels at 1 month & 1 year were as follows; LD: 5.6±1.7 & 5.0±0.9ng/ml, 240.8±43.1 & 206.5±27.2ng[bull]hr/ml, and VLD: 4.8±1.2 & 3.4±0.9ng/ml, 211.7±37.2 & 149.9±40.8ng[bull]hr/ml. There were significant differences in tacrolimus trough level and eAUC in 1, 3, 6 months and 1 year after transplantation (p<0.05).
Conclusion: The very low-dose TACER regimen under eAUC monitoring showed similar acute rejection and graft / patient survivals to low-dose after kidney transplantation.
CITATION INFORMATION: Hidaka Y, Yamanaga S, Toyoda M, Narumi S, Watarai Y, Kobayashi T. One Year Outcomes of Low-Dose vs Very Low-Dose Extended-Release Tacrolimus/Mycophenolate mofetil in De Novo Kidney Transplantation: A Multi-Center Randomized Controlled Trial. Am J Transplant. 2017;17 (suppl 3).
To cite this abstract in AMA style:Hidaka Y, Yamanaga S, Toyoda M, Narumi S, Watarai Y, Kobayashi T. One Year Outcomes of Low-Dose vs Very Low-Dose Extended-Release Tacrolimus/Mycophenolate mofetil in De Novo Kidney Transplantation: A Multi-Center Randomized Controlled Trial. [abstract]. Am J Transplant. 2017; 17 (suppl 3). https://atcmeetingabstracts.com/abstract/one-year-outcomes-of-low-dose-vs-very-low-dose-extended-release-tacrolimusmycophenolate-mofetil-in-de-novo-kidney-transplantation-a-multi-center-randomized-controlled-trial/. Accessed March 7, 2021.
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