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A randomized double-blind, placebo controlled trial of steroid withdrawal after pediatric renal transplantation

M R Benfield1, S Bartosh, D Ikle

  • 1Division of Pediatric Nephrology, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, USA. Benfield@uab.edu

American Journal of Transplantation : Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons
|August 12, 2009
PubMed

Insights

Steroid withdrawal after pediatric transplantation, using a specific immunosuppression regimen, improved allograft survival but increased complications. This approach is not recommended for routine pediatric use due to safety concerns.

Area of Science:

  • Pediatric Transplantation Immunology
  • Immunosuppressive Therapy

Background:

  • Steroids are a cornerstone of immunosuppression post-transplantation, but associated with significant side effects in pediatric patients.
  • Hypothesis: Robust early immunosuppression could permit safe steroid withdrawal, reducing complications and improving outcomes.

Purpose of the Study:

  • To evaluate the efficacy and safety of early steroid withdrawal in pediatric transplant recipients.
  • To assess the impact on allograft survival, rejection rates, growth, and complications.

Main Methods:

  • 274 pediatric subjects received anti-CD25 antibody, sirolimus, calcineurin inhibitor, and steroids.
  • At 6 months, subjects were randomized to steroid withdrawal (n=73) or continued low-dose steroids (n=59).
  • Study terminated early due to post-transplant lymphoproliferative disorder incidence.

Main Results:

  • No difference in standardized height z-score at 18 months; greater height velocity in steroid withdrawal group (p=0.033).
  • No difference in acute rejection episodes between groups.
  • Significantly higher 3-year allograft survival in steroid withdrawal group (98.6%) vs. control (84.5%) (p=0.002).

Conclusions:

  • The immunosuppressive protocol allowed steroid withdrawal without increasing rejection or allograft loss.
  • However, the high incidence of complications, including post-transplant lymphoproliferative disorder, precludes recommendation for routine pediatric use.

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