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

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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.

Prokurat, Sylwester (författare)
Vondrak, Karel (författare)
Watson, Alan R (författare)
Hughes, David A (författare)
Marks, Stephen D (författare)
Moghal, Nadeem E (författare)
Fitzpatrick, Maggie M (författare)
Milford, David V (författare)
Saleem, Moin A (författare)
Jones, Caroline A (författare)
Friman, Styrbjörn,1948Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för kirurgi,Institute of Clinical Sciences, Department of Surgery(Swepub:gu)xfrist (författare)
Van Damme-Lombaerts, Rita (författare)
Janssen, Francoise (författare)
Hamer, Clare (författare)
Rhodes, Sarah (författare)
Göteborgs universitetInstitutionen för kliniska vetenskaper, Avdelningen för kirurgi (creator_code:org_t)

Ingår i:Pediatric nephrology (Berlin, Germany): Springer Science and Business Media LLC24:1, s. 177-820931-041X1432-198X

Av författaren/redakt...: Webb, Nicholas J ...; Prokurat, Sylwes ...; Vondrak, Karel; Watson, Alan R; Hughes, David A; Marks, Stephen D; visa fler...; Moghal, Nadeem E; Fitzpatrick, Mag ...; Milford, David V; Saleem, Moin A; Jones, Caroline ...; Friman, Styrbjör ...; Van Damme-Lombae ...; Janssen, Francoi ...; Hamer, Clare; Rhodes, Sarah; visa färre...

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