title: A 12-month single arm pilot study to evaluate the efficacy and safety of sirolimus in combination with tacrolimus in kidney transplant recipients at high immunologic risk.
abstract: The optimal immunosuppressive strategy for renal transplant recipients at high immunologic risk remains a topic of investigation. This prospective single arm pilot study was undertaken to evaluate the safety and efficacy of a combined tacrolimus and sirolimus regimen in recipients at immunological high risk and to compare outcomes with a contemporaneous control group received tacrolimus and mycophenolate mofetil. Patients that received a renal allograft between 2010 and 2011 at high risk (defined as panel reactive antibodies > 50%, 4 or more human leukocyte antigen mismatches, or retransplantation) were enrolled. All patients received basiliximab induction and corticosteroids. A total of 28 recipients treated with tacrolimus and sirolimus were enrolled in this study and 69 recipients were retrospectively reviewed as a control group. The sirolimus group showed a higher, but not statistically significant, incidence of biopsy proven acute rejection and a lower glomerular filtration rate than the control group. Furthermore, sirolimus group was associated with significant increases in BKV infection (P = 0.031), dyslipidemia (P = 0.004), and lymphocele (P = 0.020). The study was terminated prematurely due to a high incidence of adverse events. A de novo tacrolimus/sirolimus combination regimen may not be an ideal choice for recipients at high immunological risk.
authors.affiliation: The Research Institute for Transplantation, Yonsei University College of Medicine, Seoul, Korea. ; Department of Transplantation Surgery, Severance Hospital, Yonsei University Health System, Seoul, Korea.
authors.forename: Juhan
authors.identifier: 0000-0003-4910-2596
authors.initials: J
authors.lastname: Lee
authors.affiliation: Department of Surgery, CHA Bundang Medical Center, CHA University, Seongnam, Korea.
authors.forename: Jung Jun
authors.identifier: 0000-0002-2848-3580
authors.initials: JJ
authors.lastname: Lee
authors.affiliation: The Research Institute for Transplantation, Yonsei University College of Medicine, Seoul, Korea. ; Division of Nephrology, Department of Internal Medicine, Severance Hospital, Yonsei University Health System, Seoul, Korea.
authors.forename: Beom Seok
authors.initials: BS
authors.lastname: Kim
authors.affiliation: The Research Institute for Transplantation, Yonsei University College of Medicine, Seoul, Korea. ; Department of Transplantation Surgery, Severance Hospital, Yonsei University Health System, Seoul, Korea.
authors.forename: Jae Geun
authors.initials: JG
authors.lastname: Lee
authors.affiliation: The Research Institute for Transplantation, Yonsei University College of Medicine, Seoul, Korea. ; Department of Transplantation Surgery, Severance Hospital, Yonsei University Health System, Seoul, Korea.
authors.forename: Kyu Ha
authors.initials: KH
authors.lastname: Huh
authors.affiliation: Department of Laboratory Medicine, Severance Hospital, Yonsei University Health System, Seoul, Korea.
authors.forename: Yongjung
authors.initials: Y
authors.lastname: Park
authors.affiliation: The Research Institute for Transplantation, Yonsei University College of Medicine, Seoul, Korea. ; Department of Transplantation Surgery, Severance Hospital, Yonsei University Health System, Seoul, Korea.
authors.forename: Yu Seun
authors.identifier: 0000-0002-5105-1567
authors.initials: YS
authors.lastname: Kim
mesh_terms: D000328:Adult; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D006084:Graft Rejection / Q000175:diagnosis / Q000209:etiology* / Q000517:prevention & control*; D006801:Humans; D016867:Immunocompromised Host; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects; D016030:Kidney Transplantation / Q000009:adverse effects*; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D020123:Sirolimus / Q000008:administration & dosage* / Q000009:adverse effects; D015996:Survival Rate; D016559:Tacrolimus / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D020123:Sirolimus; D016559:Tacrolimus
keywords: Graft Rejection; Kidney Transplantation; Sirolimus; Tacrolimus