Multicentre prospective randomised trial of tacrolimus, azathioprine and prednisolone with or without basiliximab: two-year follow-up data.
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.
Webb
Nicholas J A
NJ
Department of Paediatric Nephrology, Royal Manchester Children's Hospital, Manchester, M27 4HA, UK. nicholas.webb@cmmc.nhs.uk
Prokurat
Sylwester
S
Vondrak
Karel
K
Watson
Alan R
AR
Hughes
David A
DA
Marks
Stephen D
SD
Moghal
Nadeem E
NE
Fitzpatrick
Maggie M
MM
Milford
David V
DV
Saleem
Moin A
MA
Jones
Caroline A
CA
Friman
Styrbjorn
S
Van Damme-Lombaerts
Rita
R
Janssen
Francoise
F
Hamer
Clare
C
Rhodes
Sarah
S
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*
D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D000077552:Basiliximab; D011239:Prednisolone; D001379:Azathioprine; D016559:Tacrolimus