Five-year experience using sirolimus-based, calcineurin inhibitor-free immunosuppression in pediatric renal transplantation

• Published in: Pediatric transplantation Vol. 15; no. 4; pp. 437 - 441
• Main Authors: Hymes, Leonard C., Warshaw, Barry L.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.06.2011; Blackwell
• Subjects: Antibodies, Monoclonal - adverse effects; Antibodies, Monoclonal - therapeutic use; Biological and medical sciences; Biopsy; BK virus; Calcineurin; Calcineurin Inhibitors; Child; Child, Preschool; Children; Cholesterol; Cohort Studies; Cytomegalovirus; Diabetes mellitus; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Edema; Epstein-Barr virus; Female; Follow-Up Studies; Fundamental and applied biological sciences. Psychology; Fundamental immunology; General aspects; Graft Rejection; Graft Survival; Humans; Immunosuppression; Immunosuppressive Agents - adverse effects; Immunosuppressive Agents - therapeutic use; immunosuppressive treatment; Infant; Kidney transplantation; Kidney Transplantation - adverse effects; Kidney Transplantation - immunology; Kidney Transplantation - methods; Lymph; Male; Medical sciences; Nephropathy; Nephrotic syndrome; pediatric kidney transplantation; Pediatrics; Postoperative Care - methods; Prednisone; Proteinuria; Recombinant Fusion Proteins - adverse effects; Recombinant Fusion Proteins - therapeutic use; Renal function; Retrospective Studies; Risk Assessment; Risk groups; sirolimus; Sirolimus - adverse effects; Sirolimus - therapeutic use; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Surgery of the urinary system; Survival; Survival Analysis; Thrombocytopenia; Time Factors; Tissue, organ and graft immunology; Transplantation Immunology; Ulcers; Viremia; Antineoplastic agent; Pediatrics; Calcineurin inhibitor; Sirolimus; pediatric kidney transplantation; Homotransplantation; Kidney; Macrocycle; Surgery; Graft; Protein synthesis inhibitor; Child; Human; immunosuppressive treatment; Lactone; Macrolide; calcineurin inhibitors; Antibiotic; Experience; Immunosuppression; Treatment; Urinary system; Immunosuppressive agent; Antibacterial agent; Kidney transplantation
• ISSN: 1397-3142; 1399-3046
• DOI: 10.1111/j.1399-3046.2011.01477.x

Hymes LC, Warshaw BL. Five‐year experience using sirolimus‐based, calcineurin inhibitor‐free immunosuppression in pediatric renal transplantation.
Pediatr Transplantation 2011: 15: 437–441. © 2011 John Wiley & Sons A/S. :  From December 2003 to December 2008, we employed a protocol for withdrawing TAC and converting to SRL in a cohort of low‐risk renal pediatric transplant recipients. We report our experience in these children with respect to graft survival, AR episodes, renal function, and adverse events. All patients received basiliximab induction and TAC, MMF, and prednisone. Criteria for conversion to SRL included first transplants without histologic evidence for AR on three‐month surveillance biopsies. Patient exclusion criteria included AR prior to or before surveillance biopsies, polyoma (BK) virus nephropathy, a history of nephrotic syndrome, or multiple organ transplants. Fifty‐one of 137 patients who received transplants from December 2003 to December 2008 met criteria for withdrawal of TAC and were converted to SRL. SRL was discontinued in 11 children because of adverse events within 12 months after conversion. Among the remaining 40 patients, actuarial graft survival was 91% at five yr. AR occurred in 13% of patients within one yr after conversion. Complications from SRL included aphthous ulcers (30%); viremia with BK virus (20%), EBV (13%), and CMV (3%); proteinuria (7%); elevated cholesterol (7%); diabetes mellitus (2%); thrombocytopenia (2%); erectile dysfunction (2%); and lymph edema (2%). SRL was discontinued in 20%, predominantly for aphthous ulcers. Our experience with SRL‐based immunosuppression demonstrates that a CNI‐free regimen can be successful in lower‐risk patients meeting our selection criteria. Aphthous ulcers and BK virus viremia were the most prevalent adverse events.