Multicentre prospective randomised trial of tacrolimus, azathioprine and prednisolone with or without basiliximab: two-year follow-up data

Abstract

A total of 192 children and adolescents undergoing renal transplantation were randomly chosen to receive tacrolimus, azathioprine and corticosteroids (TAS, n = 93) or tacrolimus, azathioprine, corticosteroids and two doses of basiliximab (TAS + B, n = 99). Six-month outcome data have previously been reported; this manuscript reports the 2-year data. Complete 2-year data were available on 164 (85.4%) of the original 192 patients. There was a single death in the TAS arm. Kaplan-Meier estimates of survival free of graft loss at 2 years were 94.9% in the TAS + B arm and 89.6% in the TAS arm [hazard ratio (HR) 0.52; 95% confidence interval (CI) 0.17 to 1.54, P = 0.23]. Estimates of survival free from rejection at 2 years were 75.2% in the TAS + B arm and 68.7% in the TAS arm (HR 0.81; 95% CI 0.46 to 1.40, P = 0.44). The mean estimated glomerular filtration rate (GFR) at 2 years, was 65.8 ml/min per 1.73 m(2) body surface area in the TAS arm and 66.7 ml/min per 1.73 m(2) in the TAS + B arm (P = 0.78). Blood pressure and cholesterol levels were similar in the two arms, and there was no evidence of a difference in the incidence of infection or malignancy. These data provide further evidence of a lack of benefit associated with the addition of basiliximab to a TAS regimen for European paediatric renal transplant recipients at low immunological risk.

Pediatric kidney transplantation: a review

“…46,47 However, a subsequent randomized multicenter European trial showed that, at 2-year follow-up, basiliximab showed no rejection, malignancy, or cardiovascular protection effect among low-immunologic risk pediatric patients on a maintenance regimen of tacrolimus, azathioprine, and steroids. 48 These differences suggest that the immunologic risk of the recipient and composition of the maintenance regimen are important factors to consider when using induction therapy.…”

Immunosuppressive therapy for kidney transplantation in children and adolescents: systematic review and economic evaluation

“…Although RCTs in mixed populations were identified, none included subgroup analysis by age -providing separate results for children/adolescents and adultsand were therefore excluded from the review (a list of these records can be found in Appendix 2, Table 136). Three RCTs (published in one abstract 72 and seven papers [73][74][75][76][77][78][79] ) met the inclusion criteria.…”

“…In summary, three RCTs (published in seven papers [73][74][75][76][77][78][79] and one abstract 72 ) were found eligible and are included in this review (Table 10). • Abstract, n = 332…”

“…Two RCTs of induction therapy 73,75 (reported in four publications [73][74][75][76] and one abstract 72 ) in children and adolescents were identified in the review; the population characteristics are summarised in No non-RCTs in the child/adolescent population evaluated induction therapies.…”

Basiliximab

“…Discussion is supplemented with retrospective analyses. In pediatric patients, randomized studies have compared basiliximab with placebo [50] or no induction [51,52] (section 4.2). [18,[31][32][33][34][35][36][37] The efficacy of basiliximab coadministered with corticosteroid-sparing (section 4.1.5) [38][39][40][41][42] or CNI-sparing (section 4.1.6) [43][44][45][46][47] regimens, or its use in diabetic [26,28,48] or elderly [49] patients (section 4.1.7), is also discussed.…”