Minimizing steroid exposure in pediatric renal transplant recipients can improve linear growth and reduce metabolic disorders. This randomized multicenter study investigated the impact of early steroid withdrawal on mean change in height standard deviation score (SDS) and the safety and efficacy of two immunosuppressive regimens during the first 6 months after transplantation. Children received tacrolimus, MMF, two doses of daclizumab and steroids until day 4 (TAC/MMF/DAC, n=98) or tacrolimus, MMF and standard-dose steroids (TAC/MMF/STR, n=98). Mean change in height SDS was 0.16 +/- 0.32 with TAC/MMF/DAC and 0.03 +/- 0.32 with TAC/MMF/STR. The mean treatment group difference was 0.13 (p < 0.005 [95% CI 0.04-0.22]), 0.21 in prepubertal (p = 0.009 [95% CI 0.05-0.36]) and 0.05 in pubertal children (p = ns). Frequency of biopsy-proven acute rejection was 10.2%, TAC/MMF/DAC, and 7.1%, TAC/MMF/STR. Patient and graft survival and renal function were similar. Significantly greater reductions in total cholesterol and triglycerides but significantly higher incidences of infection and anemia were found with TAC/MMF/DAC (p < 0.05 all comparisons). Early steroid withdrawal significantly aided growth at 6 months more so in prepubertal than pubertal children. This was accompanied by significantly better lipid and glucose metabolism profiles without increases in graft rejection or loss.

Astellas Pharma Europe Ltd Staines UK

Azienda Ospedaliera di Padova Dipartimento de Pediatria Padova Italy

Birmingham Children's Hospital Birmingham UK

Children's Memorial Health Institute Warsaw Poland

Great Ormond Street Hospital for Children London UK

Hopital Femme Mère Enfant Lyon France

Hopital Robert Debre Paris France

Nottingham University Hospitals Nottingham UK

Rabin Medical Center Petah Tikva Israel

Royal Hospital for Sick Children Yorkhill Glasgow UK

Royal Manchester Children's Hospital Manchester UK

Semmelweis University of Medicine Budapest Hungary

St James University Hospital Leeds UK

Universitair Ziekenhuis KU Leuven Belgium

University Children's Hospital Heidelberg Germany

University Hospital Motol Prague Czech Republic

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