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
Journal of Korean Medical Science
; : 682-687, 2015.
Article
in English
| WPRIM (Western Pacific)
| ID: wpr-99233
Responsible library:
WPRO
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.
Full text:
Available
Database:
WPRIM (Western Pacific)
Main subject:
Survival Rate
/
Longitudinal Studies
/
Kidney Transplantation
/
Treatment Outcome
/
Immunocompromised Host
/
Tacrolimus
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Sirolimus
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Drug Therapy, Combination
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Graft Rejection
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Immunosuppressive Agents
Type of study:
Etiology study
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Observational study
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Risk factors
Limits:
Adult
/
Female
/
Humans
/
Male
Language:
English
Journal:
Journal of Korean Medical Science
Year:
2015
Document type:
Article