Pediatric Nephrology

, Volume 24, Issue 1, pp 177–182

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

  • Nicholas J. A. Webb
  • Sylwester Prokurat
  • Karel Vondrak
  • Alan R. Watson
  • David A. Hughes
  • Stephen D. Marks
  • Nadeem E. Moghal
  • Maggie M. Fitzpatrick
  • David V. Milford
  • Moin A. Saleem
  • Caroline A. Jones
  • Styrbjorn Friman
  • Rita Van Damme-Lombaerts
  • Franςoise Janssen
  • Clare Hamer
  • Sarah Rhodes
Original Article

DOI: 10.1007/s00467-008-0931-x

Cite this article as:
Webb, N.J.A., Prokurat, S., Vondrak, K. et al. Pediatr Nephrol (2009) 24: 177. doi:10.1007/s00467-008-0931-x

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 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.

Keywords

Renal transplantation Basiliximab Interleukin-2 receptor (IL2R) antibodies Graft survival Acute rejection Long-term survival 

Copyright information

© IPNA 2008

Authors and Affiliations

  • Nicholas J. A. Webb
    • 1
  • Sylwester Prokurat
    • 2
  • Karel Vondrak
    • 3
  • Alan R. Watson
    • 4
  • David A. Hughes
    • 5
  • Stephen D. Marks
    • 6
  • Nadeem E. Moghal
    • 7
  • Maggie M. Fitzpatrick
    • 8
  • David V. Milford
    • 9
  • Moin A. Saleem
    • 10
  • Caroline A. Jones
    • 11
  • Styrbjorn Friman
    • 12
  • Rita Van Damme-Lombaerts
    • 13
  • Franςoise Janssen
    • 14
  • Clare Hamer
    • 15
  • Sarah Rhodes
    • 16
  1. 1.Department of Paediatric NephrologyRoyal Manchester Children’s HospitalManchesterUK
  2. 2.Department of Paediatric NephrologyChildren’s Memorial Health InstituteWarsawPoland
  3. 3.Pediatric ClinicUniversity Hospital MotolPragueCzech Republic
  4. 4.Children and Young People’s Kidney UnitNottinghamUK
  5. 5.Department of Paediatric NephrologyRoyal Hospital for Sick ChildrenGlasgowUK
  6. 6.Department of Paediatric NephrologyGreat Ormond Street HospitalLondonUK
  7. 7.Department of Paediatric NephrologyRoyal Victoria InfirmaryNewcastle upon TyneUK
  8. 8.Department of Paediatric NephrologySt James’s University HospitalLeedsUK
  9. 9.Department of Paediatric NephrologyBirmingham Children’s HospitalBirminghamUK
  10. 10.Department of Paediatric NephrologyBristol Children’s HospitalBristolUK
  11. 11.Department of Paediatric NephrologyRoyal Liverpool Children’s HospitalLiverpoolUK
  12. 12.SU/Sahlgrenska University HospitalGothenburgSweden
  13. 13.U2 GasthuisbergLeuvenBelgium
  14. 14.Hopital Universitaire des Enfants Reine FabiolaBrusselsBelgium
  15. 15.Department of TransplantationManchester Royal InfirmaryManchesterUK
  16. 16.Research and Development DepartmentPennine Acute Hospitals NHS TrustManchesterUK

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