• Citer

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

par Webb, Nicholas N.J.A.;Prokurat, Sylwester;Vondrak, Karel;Watson, Alan;Hughes, David D.E.;Marks, Stephen S.D.;Moghal, Nadeem N.E.;Fitzpatrick, Maggie M.M.;Milford, David D.V.;Saleem, Moin M.A.;Jones, A.;Friman, Styrbjorn;Damme-Lombaerts, Rita;Janssen, Françoise ;Hamer, Clare;Rhodes, Sarah
Référence Pediatric nephrology, 24, 1, page (177-182)
Publication Publié, 2009

Article révisé par les pairs

• Détails
• Contenu

Résumé :

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 m2 body surface area in the TAS arm and 66.7 ml/min per 1.73 m2 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. © IPNA 2008.