Impacts of Mycophenolate Mofetile Addition to Very Low Exposure Everolimus and Calcineurine Inhibitor Based Immunosuppression in De Novo Kidney Transplantation
1Transplant Surgery, Nagoya Daini Red Cross Hospital, Nagoya, Japan
2Applied Immunity, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Meeting: 2015 American Transplant Congress
Abstract number: B71
Keywords: Immunosuppression, Kidney transplantation, Pharmacokinetics
Session Information
Session Name: Poster Session B: Clinical Science: Kidney Immunosuppression: Novel Agents
Session Type: Poster Session
Date: Sunday, May 3, 2015
Session Time: 5:30pm-6:30pm
Presentation Time: 5:30pm-6:30pm
Location: Exhibit Hall E
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 under the concern regarding to higher 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 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 21 (12-30) 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 (3.8±1.9 and 42±17 ng/ml) compared to EVR group (5.7±1.6ng/ml and 72±37 ng/ml) (p<0.05). Renal function expressed as eGFR was similar 47.7±14.1 in EVR group and 39.7±10.0 in EVR+MMF group. 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, 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 no incidence of DSA production in both groups at 1 year.
Conclusions: MMF addition with further reduction of EVR and CNI did not lead benefit in eGFR, proteinuria, protocol biopsy findings and DSA production. Further evaluation is needed on DSA production with longer term follow-up.
To cite this abstract in AMA style:
Watarai Y, Okada M, Futamura K, Ito K, Yamamoto T, Tsujita M, Hiramitsu T, Goto N, Narumi S, Kobayashi T. Impacts of Mycophenolate Mofetile Addition to Very Low Exposure Everolimus and Calcineurine Inhibitor Based Immunosuppression in De Novo Kidney Transplantation [abstract]. Am J Transplant. 2015; 15 (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/. Accessed May 9, 2025.« Back to 2015 American Transplant Congress