Complete steroid avoidance is effective and safe in children with renal transplants: a multicenter randomized trial with three-year follow-up.
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.
California Pacific Medical Center, Sutter Health Care, San Francisco, CA, USA. sarwalm@cpmcri.org
M M
MM
Sarwal
R B
RB
Ettenger
V
V
Dharnidharka
M
M
Benfield
R
R
Mathias
A
A
Portale
R
R
McDonald
W
W
Harmon
D
D
Kershaw
V M
VM
Vehaskari
E
E
Kamil
H J
HJ
Baluarte
B
B
Warady
L
L
Tang
J
J
Liu
L
L
Li
M
M
Naesens
T
T
Sigdel
Janie
J
Waskerwitz
O
O
Salvatierra
D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D007223:Infant; D007231:Infant, Newborn; D016030:Kidney Transplantation; D008297:Male; D013256:Steroids / Q000008:administration & dosage*; D055815:Young Adult
D007166:Immunosuppressive Agents; D013256:Steroids