Complete steroid avoidance is effective and safe in children with renal transplants: a multicenter randomized trial with three-year follow-up

Abstract

To determine whether steroid avoidance in pediatric kidney transplantation is safe and efficacious, a randomized, multicenter trial was performed in 12 pediatric kidney transplant centers. One hundred thirty children receiving primary kidney transplants were randomized to steroid-free (SF) or steroid-based (SB) immunosuppression, with concomitant tacrolimus, mycophenolate and standard dose daclizumab (SB group) or extended dose daclizumab (SF group). Follow-up was 3 years posttransplant. Standardized height Z-score change after 3 years follow-up was -0.99 ± 2.20 in SF versus -0.93 ± 1.11 in SB; p = 0.825. In subgroup analysis, recipients under 5 years of age showed improved linear growth with SF compared to SB treatment (change in standardized height Z-score at 3 years -0.43 ± 1.15 vs. -1.07 ± 1.14; p = 0.019). There were no differences in the rates of biopsy-proven acute rejection at 3 years after transplantation (16.7% in SF vs. 17.1% in SB; p = 0.94). Patient survival was 100% in both arms; graft survival was 95% in the SF and 90% in the SB arms (p = 0.30) at 3 years follow-up. Over the 3 year follow-up period, the SF group showed lower systolic BP (p = 0.017) and lower cholesterol levels (p = 0.034). In conclusion, complete steroid avoidance is safe and effective in unsensitized children receiving primary kidney transplants.

Trial registration: ClinicalTrials.gov NCT00141037.

Figure 1. Estimated group mean standardized change in growth (Z-score) among infants and young children (A), mean eGFR level (by Schwartz method) (B), mean diastolic (C) and systolic (D) blood pressure levels and serum cholesterol (E) and triglyceride (F) levels from transplantation up to three year

Values are estimated group means ± Standard Error (SE) from a repeated measure mixed model with treatment and time (in study month) as main effects, and treatment by time interaction. The P value for overall treatment effect in each analysis is given.

Figure 2. Change in height Z-score from baseline amongst infants and young children < 5 years of age

Change in height Z-score from baseline tended to be different between the SF and the SB arm in the first months after transplantation, but this effect was lost by 1 year after transplantation (Wilcoxon p=0.79 at 1 year and p=0.84 at 3 years after transplantation).