De novo Therapy with Everolimus, Low‐Dose Ciclosporine A, Basiliximab and Steroid Elimination in Pediatric Kidney Transplantation

• Published in: American journal of transplantation Vol. 10; no. 10; pp. 2349 - 2354
• Main Authors: Pape, L., Offner, G., Kreuzer, M., Froede, K., Drube, J., Kanzelmeyer, N., Ehrich, J. H. H., Ahlenstiel, T.
• Format: Journal Article
• Language: English
• Published: Malden, USA Blackwell Publishing Inc 01.10.2010; Wiley
• Subjects: Acute allograft rejection; Adolescent; Antibacterial agents; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antibodies, Monoclonal - administration & dosage; Basiliximab; Biological and medical sciences; Child; Child, Preschool; Cyclosporine - administration & dosage; Cytomegalovirus; Cytomegalovirus Infections - prevention & control; Everolimus; Female; General aspects; Humans; Immunosuppressive Agents - administration & dosage; Infant; Kidney Transplantation - methods; Kidney Transplantation - pathology; Male; Medical sciences; mTOR inhibitor; pediatric kidney transplantation; Pharmacology. Drug treatments; Prospective Studies; Recombinant Fusion Proteins - administration & dosage; Sirolimus - administration & dosage; Sirolimus - analogs & derivatives; steroid withdrawal; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Surgery of the urinary system; Treatment Outcome; Steroid; Graft(material); Pediatrics; Calcineurin inhibitor; Acute allograft rejection; Homograft; pediatric kidney transplantation; Monoclonal antibody; Homotransplantation; Kidney; Surgery; Treatment withdrawal; Immunotherapy; mTOR inhibitor; Graft; Protein synthesis inhibitor; Child; Everolimus; steroid withdrawal; Human; Corticosteroid; Acute; Low dose; Elimination; Lactone; Macrolide; De novo; Immunomodulator; Rejection; Treatment; Urinary system; Basiliximab; Immunosuppressive agent; Antibacterial agent; Kidney transplantation
• ISSN: 1600-6135; 1600-6143
• DOI: 10.1111/j.1600-6143.2010.03266.x

The number of acute rejections and infections after pediatric kidney transplantation (KTX) could not be reduced in the last years. To reduce these events, we investigated a new immunosuppressive protocol in a prospective trial. After KTX, 20 children (median age 12 years, range 1–17) were initially treated with Basiliximab, ciclosporine A (CsA) (trough‐level = C0 200–250 ng/mL) and prednisolone. After 2 weeks, CsA dose was reduced to 50% (C0 75–100 ng/mL, after 6 months: 50–75 ng/mL) and everolimus (1.6 mg/m2/day) was started (C0 3–6 ng/mL). Six months after KTX prednisolone was set to alternate dose and stopped 3 months later. All 20 protocol biopsies 6 months after KTX showed no acute rejection or borderline findings. Indication biopsies resulted in no acute rejections and two borderline findings. Mean glomerular filtration rate (GFR) 1 year after KTX was 71 ± 25 mL/min/1.73 m2. Without cytomegalovirus (CMV)‐prophylaxis, only two primary CMV infections were seen despite a donor/recipient‐CMV‐constellation pos./neg. in 10/20 children. In pediatric KTX, de novo immunosuppression with low‐dose CsA, everolimus and steroid withdrawal after 9 months led to promising results according to numbers of acute rejections and infections. Further follow up is needed. Future larger trials will have to confirm our findings. De novo immunosuppressive therapy with Everolimus, low‐dose Ciclosporine A, Basiliximab and steroid elimination in pediatric kidney transplantation leads to 100% one year graft and patient survival, good graft function, no acute rejections and a low number of infectious complications.