Benefit of Mycophenolate Mofetile Addition to Very Low Exposure Everolimus and Calcineurine Inhibitor Based Immunosuppression in De Novo Kidney Transplantation with 2 Years Follow-Up.
1Transplant Surgery, Nagoya Daini Red Cross Hospital, Nagoya, Aichi, Japan
2Kidney Transplant Surgery, Aichi Medical University, Nagoya, Aichi, Japan.
Meeting: 2016 American Transplant Congress
Abstract number: B133
Keywords: Immunosuppression, Kidney transplantation, Mycophenolate mofetil, Pharmacokinetics
Session Information
Session Name: Poster Session B: Drug Minimization
Session Type: Poster Session
Date: Sunday, June 12, 2016
Session Time: 6:00pm-7:00pm
Presentation Time: 6:00pm-7:00pm
Location: Halls C&D
Purpose: Prospective randomized study of MMF addition to everolimus (EVR) based immunosuppression in order to further reduction of EVR and CNI was evaluated in clinical outcomes as well as protocol biopsies findings and donor specific antibody (DSA) production.
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 [mu]g[bull]hr/L. The primary endpoints were the effect on eGFR, proteinuria, protocol biopsy findings and DSA production with MMF addition.
Results: With a mean observation period of 29 (19-38) months, patient and graft survival is 100% in both groups (EVR; n=15, EVR+MMF; n=15). EVR-C0 and CsA-C0 after transplant was significantly reduced in EVR+MMF group (4.1±1.6 and 40±13ng/ml) compared to EVR group (5.5±1.6ng/ml and 66±36 ng/ml) (p<0.05) at 1 and 2 years after transplant. Renal function expressed as eGFR was similar 46.9±12.7 in EVR group and 39.9±9.5 in EVR+MMF group at 2 years after transplant. Significant proteinuria, more than 500mg/day, were observed more in EVR+MMF group (33.3%) than in EVR group (6.7%) respectively. 13.3% of EVR+MMF group was treated for clinical or subclinical T cell mediated rejection after randomization, but 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 similar DSA production 0% in EVR group and 8.3% in EVR+MMF group at 2 year.
Conclusions: MMF addition with further reduction of EVR and CNI did not lead benefit in eGFR, proteinuria, protocol biopsy findings and DSA production.
CITATION INFORMATION: Watarai Y, Okada M, Futamura K, Nagai T, Yamamoto T, Tsujita M, Hiramitsu T, Goto N, Narumi S, Kobayashi T. Benefit of Mycophenolate Mofetile Addition to Very Low Exposure Everolimus and Calcineurine Inhibitor Based Immunosuppression in De Novo Kidney Transplantation with 2 Years Follow-Up. Am J Transplant. 2016;16 (suppl 3).
To cite this abstract in AMA style:
Watarai Y, Okada M, Futamura K, Nagai T, Yamamoto T, Tsujita M, Hiramitsu T, Goto N, Narumi S, Kobayashi T. Benefit of Mycophenolate Mofetile Addition to Very Low Exposure Everolimus and Calcineurine Inhibitor Based Immunosuppression in De Novo Kidney Transplantation with 2 Years Follow-Up. [abstract]. Am J Transplant. 2016; 16 (suppl 3). https://atcmeetingabstracts.com/abstract/benefit-of-mycophenolate-mofetile-addition-to-very-low-exposure-everolimus-and-calcineurine-inhibitor-based-immunosuppression-in-de-novo-kidney-transplantation-with-2-years-follow-up/. Accessed May 9, 2025.« Back to 2016 American Transplant Congress