title: 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.
authors.affiliation: Department of Paediatric Nephrology, Royal Manchester Children's Hospital, Manchester, M27 4HA, UK. nicholas.webb@cmmc.nhs.uk
authors.forename: Nicholas J A
authors.initials: NJ
authors.lastname: Webb
authors.forename: Sylwester
authors.initials: S
authors.lastname: Prokurat
authors.forename: Karel
authors.initials: K
authors.lastname: Vondrak
authors.forename: Alan R
authors.initials: AR
authors.lastname: Watson
authors.forename: David A
authors.initials: DA
authors.lastname: Hughes
authors.forename: Stephen D
authors.initials: SD
authors.lastname: Marks
authors.forename: Nadeem E
authors.initials: NE
authors.lastname: Moghal
authors.forename: Maggie M
authors.initials: MM
authors.lastname: Fitzpatrick
authors.forename: David V
authors.initials: DV
authors.lastname: Milford
authors.forename: Moin A
authors.initials: MA
authors.lastname: Saleem
authors.forename: Caroline A
authors.initials: CA
authors.lastname: Jones
authors.forename: Styrbjorn
authors.initials: S
authors.lastname: Friman
authors.forename: Rita
authors.initials: R
authors.lastname: Van Damme-Lombaerts
authors.forename: Francoise
authors.initials: F
authors.lastname: Janssen
authors.forename: Clare
authors.initials: C
authors.lastname: Hamer
authors.forename: Sarah
authors.initials: S
authors.lastname: Rhodes
mesh_terms: D000293:Adolescent; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D001379:Azathioprine / Q000627:therapeutic use*; D000077552:Basiliximab; D002648:Child; D004359:Drug Therapy, Combination; D005260:Female; D005919:Glomerular Filtration Rate; D006084:Graft Rejection / Q000276:immunology / Q000517:prevention & control*; D006801:Humans; D007165:Immunosuppression Therapy; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000276:immunology*; D008297:Male; D011239:Prednisolone / Q000627:therapeutic use*; D011446:Prospective Studies; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use; D016559:Tacrolimus / Q000627:therapeutic use*
chemical_list: D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D000077552:Basiliximab; D011239:Prednisolone; D001379:Azathioprine; D016559:Tacrolimus