Thirty-four children were entered into a pilot trial of calcineurin inhibitor avoidance after living-donor kidney transplantation. Patients were treated with anti-CD25 mAb, prednisone, mycophenolate mofetil, and sirolimus. Twenty patients were maintained on the protocol for 3 years with follow up.

One enrolled patient was not transplanted because of a donor problem, 8 terminated because of one or more rejection episodes, 4 terminated because of adverse events and 1 was lost to follow up. Two grafts were lost. One was the result of chronic rejection and the other because of post-transplantation lymphoproliferative disorder. There were no deaths. The 6 and 12 month acute rejection rates were 21.8 and 31.5%, respectively. GFR were stable throughout the course of the study, with a slight downward trend by 6 months after transplantation followed by a slight upward trend to a mean of 70 ml/. Early surveillance graft biopsies frequently showed focal interstitial mononuclear cellular infiltrates without vasculitis or tubulitis. These infiltrates disappeared without treatment. Anti-HLA class I and II antibodies were detected in three patients before transplantation. All three of these patients had acute rejections, including the two patients who lost their grafts. De novo anti-HLA Ab production occurred in only one patient after transplantation. There were two episodes of Epstein Barr virus-related posttransplantation lymphoproliferative disorder, one of which developed after the patient had been terminated from the study.

The group concluded from this study that calcineurin inhibitor-free immunosuppression can be a safe and effective treatment in pediatric living-donor renal transplantation. They emphasized that further studies be performed where modifications designed to lessen early rejection rates and decrease complications should be tested before this approach is used routinely.

Journal of the American Society of Nephrology 17(6): 1735-1745, June 2006

Written by Pasquale Casale, MD, a Contributing Editor with UroToday.

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