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Impacts of Mycophenolate Mofetile Addition to Very Low Exposure Everolimus and Calcineurine Inhibitor Based Immunosuppression in De Novo Kidney Transplantation 5 Years Results

Y. Watarai1, S. Narumi1, T. Tomosugi1, M. Okada1, K. Futamura2, M. Tsujita2, T. Hiramitsu1, T. Kobayashi3, N. Goto2

1Transplant Surgery, Nagoya Daini Red Cross Hospital, Nagoya, Japan, 2Transplant Nephrology, Nagoya Daini Red Cross Hospital, Nagoya, Japan, 3Kidney Transplant Surgery, Aichi Medical University, Nagoya, Japan

Meeting: 2019 American Transplant Congress

Abstract number: A266

Keywords: Alloantibodies, Glomerular filtration rate (GFR), Graft survival, Kidney transplantation

Session Information

Session Name: Poster Session A: Kidney Immunosuppression: Novel Regimens and Drug Minimization

Session Type: Poster Session

Date: Saturday, June 1, 2019

Session Time: 5:30pm-7:30pm

 Presentation Time: 5:30pm-7:30pm

Location: Hall C & D

*Purpose: Prospective randomized study of MMF addition to everolimus (EVR) based immunosuppression was evaluated in clinical outcomes as well as protocol biopsies findings and donor specific antibody (DSA) production with 5 years follow-up.

*Methods: Thirty de novo kidney transplant recipients were treated with reduced-exposure cyclosporine (CsA; target C0 100-150ng/ml for 2 months and consequently reduced 50ng/ml after 6 months), EVR (EVR-C0 were adjusted 5-8 ng/ml), corticosteroid and basiliximab induction. The recipients were prospectively randomized into two groups at 6 months after transplant, 1) EVR group: continuing CsA and EVR unchanged and 2) EVR+MMF group: CsA and EVR were further reduced to achieve 25-50 ng/ml in CsA-C0 and 3-5ng/ml in EVR-C0 with addition of MMF starting 1000mg/day, and adjusted to obtain MPA-AUC0-12 between 30-45 μg•hr/L. The primary endpoints were the effect on eGFR, proteinuria, protocol biopsy findings and DSA production with MMF addition after one year.

*Results: With a mean observation period of 65 (55-74) months, patient and graft survival is 100% in both groups (EVR; n=15, EVR+MMF; n=15). EVR-C0 and CsA-C0 at 1 year after transplant was significantly reduced in EVR+MMF group (4.4±1.1 and 39±25ng/ml) compared to EVR group (5.6±1.6ng/ml and 66±33ng/ml) (p<0.05). Renal function expressed as eGFR was similar 39.7±13.9 in EVR group and 37.7±11.4 in EVR+MMF group at 5 years after transplant. Significant proteinuria, more than 500mg/day, were observed more in EVR+MMF group (33%) than in EVR group (7%) respectively. One (6.7%) of EVR+MMF group was treated for clinical T cell mediated rejection at 9 months after transplant, while no others revealed clinical or subclinical T cell and antibody mediated rejection on 1- or 12-months protocol biopsies. Flow PRA and Luminex solid phase assay revealed dnDSA production of 13.3% in EVR group and 6.7% in EVR+MMF group of at 5 years after transplant(P=0.58).

*Conclusions: MMF addition with further reduction of EVR and CNI did not lead benefit in eGFR, proteinuria, protocol biopsy findings and DSA production with 5 years follow-up.

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To cite this abstract in AMA style:

Watarai Y, Narumi S, Tomosugi T, Okada M, Futamura K, Tsujita M, Hiramitsu T, Kobayashi T, Goto N. Impacts of Mycophenolate Mofetile Addition to Very Low Exposure Everolimus and Calcineurine Inhibitor Based Immunosuppression in De Novo Kidney Transplantation 5 Years Results [abstract]. Am J Transplant. 2019; 19 (suppl 3). https://atcmeetingabstracts.com/abstract/impacts-of-mycophenolate-mofetile-addition-to-very-low-exposure-everolimus-and-calcineurine-inhibitor-based-immunosuppression-in-de-novo-kidney-transplantation-5-years-results/. Accessed May 11, 2025.

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