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.
10.3346/jkms.2015.30.6.682
- Author:
Juhan LEE
1
;
Jung Jun LEE
;
Beom Seok KIM
;
Jae Geun LEE
;
Kyu Ha HUH
;
Yongjung PARK
;
Yu Seun KIM
Author Information
1. The Research Institute for Transplantation, Yonsei University College of Medicine, Seoul, Korea. yukim@yuhs.ac
- Publication Type:Original Article ; Controlled Clinical Trial ; Research Support, Non-U.S. Gov't
- Keywords:
Sirolimus;
Tacrolimus;
Kidney Transplantation;
Graft Rejection
- MeSH:
Adult;
Drug Therapy, Combination/methods;
Female;
Graft Rejection/diagnosis/*etiology/*prevention & control;
Humans;
Immunocompromised Host;
Immunosuppressive Agents/administration & dosage/adverse effects;
Kidney Transplantation/*adverse effects;
Longitudinal Studies;
Male;
Middle Aged;
Sirolimus/*administration & dosage/adverse effects;
Survival Rate;
Tacrolimus/*administration & dosage/adverse effects;
Treatment Outcome
- From:Journal of Korean Medical Science
2015;30(6):682-687
- CountryRepublic of Korea
- Language:English
-
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.
