title: Safety and efficacy of a calcineurin inhibitor avoidance regimen in pediatric renal transplantation.
abstract: Thirty-four children were entered into a pilot trial of calcineurin inhibitor avoidance after living-donor kidney transplantation, the CN-01 study. Patients were treated with anti-CD25 mAb, prednisone, mycophenolate mofetil, and sirolimus. Twenty patients were maintained on the protocol for up to 3 yr of follow-up. One enrolled patient did not receive the transplant because of a donor problem, eight terminated because of one or more rejection episodes, four terminated because of adverse events, and one was lost to follow-up. Two grafts were lost, one as a result of chronic rejection and the other as a result of posttransplantation lymphoproliferative disorder. There were no deaths. The 6- and 12-mo 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 mo after transplantation followed by a slight upward trend to a mean of 70 ml/min thereafter. Early surveillance graft biopsies frequently showed focal interstitial mononuclear cellular infiltrates without overt vasculitis or tubulitis, but these infiltrates disappeared without treatment. Anti-HLA class I and II antibodies were detected in three patients before transplantation, and all three 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. It is concluded that calcineurin inhibitor-free immunosuppression can be safe and effective in pediatric living-donor renal transplantation. However, further modifications that are designed to lessen early rejection rates and decrease complications should be tested before this approach is used routinely.
authors: Transplantation Research Center, Children's Hospital Boston, 300 Longwood Avenue, Boston, MA 02115, USA. william.harmon@childrens.harvard.edu
authors: William
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authors: Meyers
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authors: Ingelfinger
authors: Ruth
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authors: McDonald
authors: Matthew
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authors: McIntosh
authors: Martin
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authors: Spaneas
authors: Jo Ann
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authors: Palmer
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authors: Hawk
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authors: Geehan
authors: Kathryn
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authors: Tinckam
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authors: Hancock
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authors: Sayegh