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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

 Juhan Lee  ;  Jung Jun Lee  ;  Beom Seok Kim  ;  Jae Geun Lee  ;  Kyu Ha Huh  ;  Yongjung Park  ;  Yu Seun Kim 
 JOURNAL OF KOREAN MEDICAL SCIENCE, Vol.30(6) : 682-687, 2015 
Journal Title
Issue Date
Adult ; Drug Therapy, Combination/methods ; Female ; Graft Rejection/diagnosis ; Graft Rejection/etiology* ; Graft Rejection/prevention & control* ; Humans ; Immunocompromised Host ; Immunosuppressive Agents/administration & dosage ; Immunosuppressive Agents/adverse effects ; Kidney Transplantation/adverse effects* ; Longitudinal Studies ; Male ; Middle Aged ; Sirolimus/administration & dosage* ; Sirolimus/adverse effects ; Survival Rate ; Tacrolimus/administration & dosage* ; Tacrolimus/adverse effects ; Treatment Outcome
Graft Rejection ; Kidney Transplantation ; Sirolimus ; Tacrolimus
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.
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1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Laboratory Medicine (진단검사의학교실) > 1. Journal Papers
Yonsei Authors
Kim, Beom Seok(김범석) ORCID logo https://orcid.org/0000-0002-5732-2583
Kim, Yu Seun(김유선) ORCID logo https://orcid.org/0000-0002-5105-1567
Park, Yong Jung(박용정)
Lee, Jae Geun(이재근) ORCID logo https://orcid.org/0000-0002-6722-0257
Lee, Ju Han(이주한)
Huh, Kyu Ha(허규하) ORCID logo https://orcid.org/0000-0003-1364-6989
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