Prospective, randomized trial on late steroid withdrawal in pediatric renal transplant recipients under cyclosporine microemulsion and mycophenolate mofetil.
BACKGROUND
: Many transplant centers practice late steroid withdrawal after pediatric renal transplantation, but evidence-based data on the overall risk-to-benefit ratio in this patient population are lacking.


METHODS
: We therefore conducted the first prospective, randomized, open-label multicenter study to validate this strategy: 42 low-immunologic risk pediatric kidney allograft recipients, aged 10.3+/-4.3 years, on cyclosporine microemulsion, mycophenolate mofetil, and corticosteroids were randomly assigned, more than or equal to 1-year posttransplant, to continue steroids or to withdraw over 3 months. This report contains the 1-year results.


RESULTS
: In response to steroid withdrawal, patients experienced a significant catch-up growth with a mean standardized height gain of 0.3+/-0.1 standard deviation score (SDS) per year (P<0.05 vs. control), whereas mean height SDS in the control group did not change (0.0+/-0.1 SDS). Standardized body mass index declined significantly by 0.68+/-0.23 SDS after steroid withdrawal, but rose significantly by 0.26+/-0.34 SDS in the control group. Patients off steroids had less frequent arterial hypertension (50% vs. 87.5% (P<0.05) and significantly lower serum cholesterol (by 21%) and triglyceride values (by 36%) than control patients. Patient and graft survival were 100%. The incidence of acute rejection episodes in the steroid-withdrawal group was 1 of 23 (4%) compared with 1 of 19 (5%) in controls. Transplant function remained stable in both groups.


CONCLUSIONS
: Late steroid withdrawal in low-immunologic risk European pediatric kidney transplant recipients on cyclosporine microemulsion and mycophenolate mofetil is not associated with an increased rate of acute rejection episodes, enables catch-up growth and ameliorates cardiovascular risk factors.
Höcker
Britta
B
Department of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg, Germany.
Weber
Lutz T
LT
Feneberg
Reinhard
R
Drube
Jens
J
John
Ulrike
U
Fehrenbach
Henry
H
Pohl
Martin
M
Zimmering
Miriam
M
Fründ
Stefan
S
Klaus
Günter
G
Wühl
Elke
E
Tönshoff
Burkhard
B
D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000627:therapeutic use*; D001827:Body Height / Q000187:drug effects; D015992:Body Mass Index; D002648:Child; D002784:Cholesterol / Q000097:blood; D016572:Cyclosporine / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006128:Growth / Q000187:drug effects; D019382:Human Growth Hormone / Q000627:therapeutic use; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000276:immunology*; D008297:Male; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010352:Patient Dropouts / Q000706:statistics & numerical data; D018579:Patient Selection; D013375:Substance Withdrawal Syndrome / Q000473:pathology; D014280:Triglycerides / Q000097:blood
D000305:Adrenal Cortex Hormones; D007166:Immunosuppressive Agents; D014280:Triglycerides; D019382:Human Growth Hormone; D016572:Cyclosporine; D002784:Cholesterol; D009173:Mycophenolic Acid