Pediatric kidney transplantation followed by de novo therapy with everolimus, low-dose cyclosporine A, and steroid elimination: 3-year data

Transplantation. 2011 Sep 27;92(6):658-62. doi: 10.1097/TP.0b013e3182295bed.


Background: Acute rejections and infections continue to cause substantial problems for pediatric kidney transplant (KTX) patients because defining an immunosuppressive protocol capable of preventing both has been challenging. Previously, we initiated a prospective trial to evaluate an immunosuppressive regimen designed to achieve this goal. Herein, we present the results of the 3-year follow-up of this trial.

Methods: After KTX, 20 children (median age 12 years, range 1-17 years) received basiliximab, cyclosporine A (CsA) (trough-level=C0 200-250 ng/mL), and prednisolone. Two weeks post-KTX, everolimus (1.6 mg/m/day) treatment was started (C0 4-6 ng/mL), and the CsA dose was reduced by 50% (C0 75-100 ng/mL, after 6 months: C0 50-75 ng/mL). Prednisolone treatment was gradually withdrawn and was completely stopped at 9 months post-KTX.

Results: There was no loss of follow-up and no graft or patient loss during the 3-year period. Indication biopsies showed no acute rejection (Banff ≥IA). One of the patients had signs of chronic humoral rejection. Mean glomerular filtration rate measured at 1 year and 3 years post-KTX was 71±25 and 61±27 mL/min/1.73 m, respectively. In patients transitioned to adult care, mean glomerular filtration rate at 3 years was 49±13 mL/min/1.73 m (P<0.05). No cases of posttransplant lymphoproliferative disorder posttransplant lymphoproliferative disorder or polyoma nephropathy were diagnosed. After 3 years, 17 of 20 patients remained on the original immunosuppressive regimen.

Conclusions: A treatment regimen consisting of de novo immunosuppression with basiliximab, CsA, and prednisolone, followed by treatment with everolimus and low-dose CsA combined with steroid withdrawal may be a promising therapy after pediatric KTX.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Antibodies, Monoclonal / pharmacology
  • Basiliximab
  • Biopsy
  • Child
  • Child, Preschool
  • Cyclosporine / administration & dosage*
  • Everolimus
  • Female
  • Glomerular Filtration Rate
  • Humans
  • Immunosuppression Therapy
  • Immunosuppressive Agents / therapeutic use
  • Infant
  • Kidney Transplantation / methods*
  • Male
  • Prednisolone / pharmacology
  • Recombinant Fusion Proteins / pharmacology
  • Sirolimus / administration & dosage
  • Sirolimus / analogs & derivatives*
  • Steroids / administration & dosage*
  • Time Factors


  • Antibodies, Monoclonal
  • Immunosuppressive Agents
  • Recombinant Fusion Proteins
  • Steroids
  • Cyclosporine
  • Basiliximab
  • Everolimus
  • Prednisolone
  • Sirolimus