title: One-year results of basiliximab induction and tacrolimus associated with sequential steroid and MMF treatment in pediatric kidney transplant recipient.
abstract: We report the 1-year results with a triple immunosuppressive regimen in pediatric recipients of a first kidney transplant, in order to evaluate its safety and efficacy in the prevention of acute rejection and in the reduction of steroid side effects. The immunosuppression is as follows: (i) basiliximab (20 mg if body weight >30 kg; 10 mg if < 30 kg) is given pretransplant and at day 4; (ii) tacrolimus (Tac) is administered in order to obtain blood trough levels of 10-20 and 5-10 ng/ml during and after the first 2 months post-transplant, respectively; (iii) steroids are tapered during the first 6 months and then replaced by mycophenolate mofetil (depending on previous rejection episodes, infection status and the result of a routine biopsy) at a dosage of 4-600 mg/m(2) body surface area. Fifty-three children (median age 13 years, range 2-20) have entered this protocol. One-year patient and kidney survival are 100% and 94% respectively. During the first year a total of nine rejections in seven patients (13% of the cohort study) occurred, all but one responsive to steroids. Renal function was satisfactory throughout the first year (mean CrCl was 63.8 +/- 18 and 60.9 +/- 15.5 ml/min/1.73 m(2) at 6 and 12 months respectively). Subclinical signs of rejection were absent in more than 80% of biopsies (grade I Banff) at 6 months (n = 47); at the 12th month biopsy (n = 42) score I was stable in 20 patients (16 after stopping steroids) and had worsened in eight biopsies (six after stopping steroids). Major complications were insulin-dependent diabetes in three (5.6%) children with the need of insulin for a mean of 3 months; transient hyperglycemia (11 patients), treated with a dietary regimen, symptomatic viral infections (in 11 patients: two parvovirus B19, three cytomegalovirus and two Epstein-Barr virus systemic infections, three interstitial pneumonia, two BK nephritis). Tac doses more than 0.3-0.4 mg/kg/day are at significantly higher risk of viral infection. In conclusion, this immunosuppressive regimen is associated with a low percentage of clinical (13%) and subclinical rejections, but with a relatively high number of infections, prevented by a reduction in Tac doses (<0.3 mg/kg/day) during the first 2 months after transplantation. The assessment of steroid withdrawal needs a longer follow-up.
authors.affiliation: Pediatric Department, Nephrology, Dialysis and Transplant Unit, University Hospital, Via Giustiniani 3, 35128 Padua, Italy. montini@pediatria.unipd.it
authors.forename: Giovanni
authors.initials: G
authors.lastname: Montini
authors.forename: Luisa
authors.initials: L
authors.lastname: Murer
authors.forename: Luciana
authors.initials: L
authors.lastname: Ghio
authors.forename: Beatrice
authors.initials: B
authors.lastname: Pietrobon
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Ginevri
authors.forename: Mariano
authors.initials: M
authors.lastname: Ferraresso
authors.forename: Massimo
authors.initials: M
authors.lastname: Cardillo
authors.forename: Mario
authors.initials: M
authors.lastname: Scalamogna
authors.forename: Francesco
authors.initials: F
authors.lastname: Perfumo
authors.forename: Alberto
authors.initials: A
authors.lastname: Edefonti
authors.forename: Giovanni Franco
authors.initials: GF
authors.lastname: Zanon
authors.forename: Graziella
authors.initials: G
authors.lastname: Zacchello
mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000627:therapeutic use*; D000077552:Basiliximab; D001706:Biopsy; D001786:Blood Glucose / Q000378:metabolism; D002648:Child; D002675:Child, Preschool; D004334:Drug Administration Schedule; D006084:Graft Rejection / Q000188:drug therapy / Q000453:epidemiology / Q000517:prevention & control; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000276:immunology* / Q000473:pathology; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage / Q000627:therapeutic use*; D015996:Survival Rate; D016559:Tacrolimus / Q000008:administration & dosage / Q000627:therapeutic use
chemical_list: D000305:Adrenal Cortex Hormones; D000911:Antibodies, Monoclonal; D001786:Blood Glucose; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D000077552:Basiliximab; D009173:Mycophenolic Acid; D016559:Tacrolimus