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Randomized Controlled Trial
. 2006 Nov;134(11):1393-401.
doi: 10.4067/s0034-98872006001100006. Epub 2007 Jan 2.

[Early steroid withdrawal in pediatric renal transplantation]

[Article in Spanish]
Affiliations
Free article
Randomized Controlled Trial

[Early steroid withdrawal in pediatric renal transplantation]

[Article in Spanish]
Angela Delucchi B et al. Rev Med Chil. 2006 Nov.
Free article

Abstract

Background: Cardiovascular risk, growth failure and the new immunosuppressive drugs, have encouraged steroid withdrawal or total avoidance with promising results in renal transplant (Tx) immunosuppression.

Aim: To evaluate a new immunosuppressor protocol with early withdrawal of steroids in pediatric kidney transplant.

Patients and methods: Prospective study in pediatric patients older than 1 year and low immunological risk. Group A (n =28): steroids in decreasing doses until day 7 post Tx, tacrolimus (FK) and mycophenolate mofetil (MMF). Group B (n =28) control: steroids, cyclosporine and azathioprine or steroids, FK and MMF. In both groups the induction therapy included basiliximab. Anthropometric and biochemical variables (renal function, lipid profile, hematological, blood glucose and acid-base equilibrium), acute rejection and CMV infection, were evaluated. Mean values and variations for continuous variables were calculated at months 1, 6, 12 and 18.

Results: Two children were withdrawn before month 2, one had an untreatable diarrhea and the second died due to Aspergillus septicemia. Mean values at months 1, 6, 12 and 18 for groups A and B: Creatinine clearance (ml/min): 85.4 vs 89; 79.9 vs 83; 89 vs 80; 79.8 vs 80.6 (p: ns); hematocrit (%): 28.8 vs 30.4; 31.7 vs 34.4; 34.4; 32.4 vs 34.8; 34.4 vs 35.5 (p: ns). Total cholesterol (mg/dl): 151 vs 206; 139 vs 174; 138 vs 186; 140 vs 180 (p <0.05). Mean delta height/age Z score at the first year: 0.5 vs 0.15; 0.7 vs 0.22; 0.97 vs 0.25 (p <0.05). Mean systolic blood pressure Z score: 0.9 vs 1.5; 0.5 vs 0.9; -0.3 vs 0.8; 0.1 vs 1.0 (p <0.05). The height/age Z score was significantly superior in patients without steroids. A normalization of growth patterns at month 18 was observed (< 0.05). Both groups presented a negative variation of creatinine clearance during the follow-up, but it was minor in the study group (p <0.05). Two acute rejections were found in each group, and no difference in CMV infections was observed.

Conclusions: Early steroid withdrawal in pediatric renal transplant recipients was effective and safe and did not increase the risk of rejection.

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