title: 5-year follow-up of a randomized clinical study comparing everolimus plus reduced-dose cyclosporine with mycophenolate mofetil plus standard-dose cyclosporine in de novo kidney transplantation: Retrospective single center assessment.
abstract: The aim of this study is to evaluate the efficacy and safety of everolimus plus reduced-dose cyclosporine compared with mycophenolate mofetil plus standard-dose cyclosporine 5years after living donor kidney transplantation. Between March 2008 and August 2009, 24 living donor kidney transplantations were enrolled in a 2-year, multicenter, randomized phase 3 study (RAD001A1202 study). 24 recipients were randomly classified into two groups and closely observed for 5years. 13 recipients were administered steroid, reduced-dose cyclosporine, everolimus and basiliximab (EVR group). 11 recipients were administered steroid, standard-dose cyclosporine, mycophenolate mofetil and basiliximab (STD group). Two groups were compared not only in graft function including estimated glomerular filtration rate (eGFR), and proteinuria, but also in adverse events such as de novo donor-specific antibody (DSA) production, rejection, new-onset diabetes, hyperlipidemia, and cytomegalovirus (CMV) infection. No graft loss was identified in 5years. The incidences of acute T cell rejection, de novo DSA production, hyperlipidemia, and new-onset diabetes were similar. eGFR levels throughout the observation periods were similar. Three cases of proteinuria were identified in STD group. One case of proteinuria observed in EVR group was well controlled with angiotensin receptor blocker. Incidence of CMV infection in CMV antibody-positive recipients was significantly lower in EVR group. The safety and efficacy of reduced-dose cyclosporine and everolimus protocol were similar to those of standard-dose cyclosporine and mycophenolate mofetil other than for superior prevention of CMV infection.
authors.affiliation: Nagoya Daini Red Cross Hospital, Department of Transplant and Endocrine Surgery, 2-9 Myoken-cho, Showa-ku, Nagoya 466-8650, Japan. Electronic address: thira@nagoya2.jrc.or.jp.
authors.forename: Takahisa
authors.initials: T
authors.lastname: Hiramitsu
authors.affiliation: Nagoya Daini Red Cross Hospital, Department of Transplant and Endocrine Surgery, 2-9 Myoken-cho, Showa-ku, Nagoya 466-8650, Japan.
authors.forename: Manabu
authors.initials: M
authors.lastname: Okada
authors.affiliation: Nagoya Daini Red Cross Hospital, Department of Transplant and Endocrine Surgery, 2-9 Myoken-cho, Showa-ku, Nagoya 466-8650, Japan.
authors.forename: Kenta
authors.initials: K
authors.lastname: Futamura
authors.affiliation: Nagoya Daini Red Cross Hospital, Department of Transplant and Endocrine Surgery, 2-9 Myoken-cho, Showa-ku, Nagoya 466-8650, Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Yamamoto
authors.affiliation: Nagoya Daini Red Cross Hospital, Department of Transplant and Endocrine Surgery, 2-9 Myoken-cho, Showa-ku, Nagoya 466-8650, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Tsujita
authors.affiliation: Nagoya Daini Red Cross Hospital, Department of Transplant and Endocrine Surgery, 2-9 Myoken-cho, Showa-ku, Nagoya 466-8650, Japan.
authors.forename: Norihiko
authors.initials: N
authors.lastname: Goto
authors.affiliation: Nagoya Daini Red Cross Hospital, Department of Transplant and Endocrine Surgery, 2-9 Myoken-cho, Showa-ku, Nagoya 466-8650, Japan.
authors.forename: Shunji
authors.initials: S
authors.lastname: Narumi
authors.affiliation: Nagoya Daini Red Cross Hospital, Department of Transplant and Endocrine Surgery, 2-9 Myoken-cho, Showa-ku, Nagoya 466-8650, Japan.
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Watarai
authors.affiliation: Nagoya Daini Red Cross Hospital, Department of Nephrology, 2-9 Myoken-cho, Showa-ku, Nagoya 466-8650, Japan.
authors.forename: Asami
authors.initials: A
authors.lastname: Takeda
authors.affiliation: Aichi Medical University School of Medicine, Department of Kidney Disease and Transplant Immunology, 1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan.
authors.forename: Kenta
authors.initials: K
authors.lastname: Iwasaki
authors.affiliation: Aichi Medical University School of Medicine, Department of Renal Transplant Surgery, 1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan.
authors.forename: Kazuharu
authors.initials: K
authors.lastname: Uchida
authors.affiliation: Aichi Medical University School of Medicine, Department of Renal Transplant Surgery, 1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan. Electronic address: takaaki.kobayashi@aichi-med-u.ac.jp.
authors.forename: Takaaki
authors.initials: T
authors.lastname: Kobayashi
mesh_terms: D000328:Adult; D016572:Cyclosporine / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D000068338:Everolimus / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate; D006084:Graft Rejection / Q000517:prevention & control*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007518:Isoantibodies / Q000097:blood; D016030:Kidney Transplantation; D050356:Lipid Metabolism / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000627:therapeutic use*; D011507:Proteinuria; D012189:Retrospective Studies
chemical_list: D007166:Immunosuppressive Agents; D007518:Isoantibodies; D016572:Cyclosporine; D000068338:Everolimus; D009173:Mycophenolic Acid
keywords: Everolimus; Reduced­dose cyclosporine; Renal transplantation