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.
1Kidney Center, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan
2Transplant Surgery, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Aichi, Japan
3Kidney Transplantation, Aichi Medical University, Nagoya, Aichi, Japan
Meeting: 2017 American Transplant Congress
Abstract number: D87
Keywords: FK506, Immunosuppression, Pharmacokinetics
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
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 July 14, 2025.« Back to 2017 American Transplant Congress