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Optimization of Extended-Release Tacrolimus Dose with Mycophenolate Mofetile Based Immunosuppression in De Novo Kidney Transplant Recipients: 2 Years Outcome.

Y. Watarai,1 S. Narumi,1 M. Okada,1 R. Kimura,1 K. Hatazoe,1 K. Futamura,1 T. Yamamoto,1 T. Hiramitsu,1 M. Tsujita,1 N. Goto,1 T. Kobayashi.2

1Transplant Surgery, Nagoya Daini Red Cross Hospital, Nagoya, Aichi, Japan
2Kidney Transplant Surgery, Aichi Medical University, Nagakute, Aichi, Japan

Meeting: 2017 American Transplant Congress

Abstract number: D86

Keywords: Alloantibodies, Calcineurin, Kidney transplantation, Mycophenolate mofetil

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 been accepted in kidney transplantation, however its optimal dosing are not well determined. We have validated the institutional subgroup analysis of multi-center randomized controlled trial to optimize TACER dose with mycophenolate mofetile (MMF) .

Patients and Methods: Fifty Living-donor kidney transplant recipients were prospectively randomized into two group, 1) Low dose (LD) group (n=26) ; targeting tacrolimus area under curve profiles (TAC-AUC) 0-24 250ng[bull]hr/ml during the first 1 months and reduced to 200ng[bull]hr/ml after 3 months. 2) Very low dose (VLD) group (n=24); targeting TAC-AUC0-24 200ng[bull]hr/ml during the first 1 months and reduced to 150ng[bull]hr/ml after 3 months. All patients received MMF, corticosteroid and basiliximab induction. MMF was adjusted to achieve MPA-AUC0-12 between 30-60 [mu]g[bull]hr/L. Protocol biopsy were evaluated after 1 and 12 months. Donor specific antibody(DSA)production was also evaluated annually.

Results: With a mean observation of 31 months (16-47), patients and graft survival are 100% in both groups. Mean tacrolimus trough concentration at 1 month, 1 and 2 years after transplant was 5.5±1.8, 5.1±0.9 and 4.9±1.0 ng/ml in LD group, and 4.7±1.1, 3.1±0.6 and 3.7±0.9ng/ml in VLD group. Significant difference in tacrolimus trough level was observed from 3 months to 2 year after transplant between LD and VLD group (p<0.05). Incidence of T cell mediated rejection was similar among both group (0% in LD group and 8.3% in VLD group), while incidence of CMV infection was reduced in VLD group (16.7%) compared to LD group (30.7%) respectively. Mean eGFR were equivalent between the two groups and maintained at 48.6±10.9 and 54.2±12.8ml/min/1.73m2 in LD group and 51.2±12.1 and 51.8±12.4ml/min/1.73m2 in VLD group at 1 and 2 year after transplant. Luminex solid phase assay revealed similar incidence of DSA production in both group (0% in LD group and 8.3% in VLD group at 2 years)(P>0.05).

Conclusions: Significant reduction of tacrolimus exposure with TACER, was achieved with excellent clinical outcomes such as patient/graft survival, graft function and DSA production rate under careful AUC monitoring of tacrolimus and MPA.

CITATION INFORMATION: Watarai Y, Narumi S, Okada M, Kimura R, Hatazoe K, Futamura K, Yamamoto T, Hiramitsu T, Tsujita M, Goto N, Kobayashi T. Optimization of Extended-Release Tacrolimus Dose with Mycophenolate Mofetile Based Immunosuppression in De Novo Kidney Transplant Recipients: 2 Years Outcome. Am J Transplant. 2017;17 (suppl 3).

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To cite this abstract in AMA style:

Watarai Y, Narumi S, Okada M, Kimura R, Hatazoe K, Futamura K, Yamamoto T, Hiramitsu T, Tsujita M, Goto N, Kobayashi T. Optimization of Extended-Release Tacrolimus Dose with Mycophenolate Mofetile Based Immunosuppression in De Novo Kidney Transplant Recipients: 2 Years Outcome. [abstract]. Am J Transplant. 2017; 17 (suppl 3). https://atcmeetingabstracts.com/abstract/optimization-of-extended-release-tacrolimus-dose-with-mycophenolate-mofetile-based-immunosuppression-in-de-novo-kidney-transplant-recipients-2-years-outcome/. Accessed May 9, 2025.

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