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Published on: November 8, 2015
Sirolimus in pediatric patients: results in the first 6 months post-renal transplant
Leonard C Hymes1, Barry L Warshaw
1Department of Pediatrics, Emory University School of Medicine, Atlanta, GA 30322, USA. leonard.hymes@oz.ped.emory.edu
Insights
Sirolimus use in pediatric kidney transplant patients showed 98% graft survival but significant adverse events like infections and wound healing issues. This suggests a sirolimus-based regimen might be excessive immunosuppression in this population.
Area of Science:
- Pediatric Nephrology
- Transplantation Immunology
- Pharmacology
Background:
- Sirolimus is an mTOR inhibitor used in immunosuppression protocols.
- Its use in pediatric renal transplantation requires careful evaluation of efficacy and safety.
- Early outcomes and adverse events in children are critical for optimizing treatment.
Purpose of the Study:
- To evaluate the safety and efficacy of sirolimus as part of maintenance immunosuppression in children undergoing renal transplantation.
- To assess patient and graft survival rates within the first six months post-transplant.
- To identify and characterize adverse events associated with sirolimus in this pediatric cohort.
Main Methods:
- Retrospective analysis of 66 children receiving renal transplants between July 2000 and January 2004.
- Maintenance immunosuppression included sirolimus, prednisone, and either tacrolimus or cyclosporine.
- Patient and graft survival, acute rejection episodes, and adverse events were monitored.
Main Results:
- 100% patient survival and 98% graft survival (65/66) at 6 months.
- Seven children experienced reversible acute rejection episodes.
- Adverse events included Epstein-Barr virus (EBV) viremia (8), post-transplant lymphoproliferative disease (PTLD) (3), cytomegalovirus (CMV) viremia (4), poor wound healing (4), and pneumonitis (3).
- Sirolimus was discontinued in 20% of patients due to adverse events, primarily wound dehiscence and pneumonitis.
- Hypercholesterolemia was observed in 33 children; thrombocytopenia was absent.
Conclusions:
- Early outcomes with sirolimus in pediatric renal transplantation are acceptable, with high graft survival rates.
- However, significant adverse events, including infections (EBV, CMV) and PTLD, along with wound healing complications and pneumonitis, are notable.
- The combination of sirolimus with other immunosuppressants like IL-2 receptor antibody and calcineurin inhibitors may represent excessive immunosuppression in pediatric renal transplant recipients, warranting careful regimen adjustment.
Abstract:
We report our experience with sirolimus in children during the first 6 months after renal transplantation. From July 2000 to January 2004, 66 children received 33 deceased donor and 33 living donor transplants. Maintenance immunosuppression included sirolimus 3 mg/m(2) in addition to prednisone and tacrolimus or cyclosporine. Patient survival was 100% and graft survival was 65 of 66. Seven children experienced acute rejection episodes. All were reversible with increased doses of corticosteroid. One case of graft failure was caused by ischemic renal injury. Adverse events included Epstein-Barr viremia (8 patients) with three cases of post-transplant lymphoproliferative disease (PTLD), cytomegalovirus viremia (4 patients), poor wound healing (4 patients), pneumonitis (3 patients), nephrotic syndrome (3 patients), perinephric abscess (1 patient) and insulin-dependant diabetes (2 patients). Sirolimus was discontinued in 13 children for adverse events predominantly for wound dehiscence and pneumonitis. Cholesterol levels >200 mg/dL were observed in 33 children. Thrombocytopenia (platelet count <140 000) was not observed. We concluded that early outcomes with sirolimus were acceptable with 98% graft survival and 11% incidence of acute rejection. Medication was discontinued in 20% for adverse events which included poor wound healing and non-infectious pneumonitis. Infections with cytomegalovirus and Epstein-Barr virus, and PTLD were also significant early complications. Therefore, a sirolimus-based regimen that is combined with both an interleukin-2 receptor antibody and a calcineurin inhibitor may be excessive immunosuppression for pediatric renal transplant recipients.
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