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. 2010 Jan 20;2010(1):CD003897. doi: 10.1002/14651858.CD003897.pub3

Parrott 2005.

Methods
  • Placebo controlled RCT

Participants
  • Setting: National multicentre (4) study

  • Country: UK

  • First (93%) or second, cadaveric (88%) or living donor kidney transplant

  • Mean age (treatment/control): 45.8/47.9 years

  • Number (treatment/control): 113 randomised, 108 analysed (52/56)

  • Sex (% male) treatment/control: 67/71

  • Exclusions: Multiorgan transplant; ABO incompatibility; positive T‐cell or B‐cell crossmatch against donor

Interventions Treatment group
  • Basiliximab: 20 mg days 0 and 4


Control group
  • Placebo


Baseline immunosuppression
  • CSA‐ME: 10 mg/kg/d, adjust to achieve trough levels of 200‐300 ng/mL (month 1), 15‐250 ng/mL (2‐12 months)

  • MMF/AZA: initiated in patients experiencing DGF and discontinued once kidney function established

  • Steroids: initiated in patients experiencing DGF and tapered to zero

Outcomes
  • Mortality

  • Graft loss

  • Acute rejection

  • DGF

Notes 1 year follow‐up
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Computer generated randomization schedule"
Allocation concealment (selection bias) Low risk "Study medication was packed sequentially and numbered... and patients were allocated to the next available treatment pack"
Blinding (performance bias and detection bias) 
 Objective outcomes Unclear risk Double‐blind, blinding of outcome assessors not stated
Blinding (performance bias and detection bias) 
 Subjective outcomes Low risk Double‐blind, blinding of outcome assessors not stated
Incomplete outcome data (attrition bias) 
 All outcomes High risk 108/113 analysed. Five excluded, 4 with no transplant, 1 with transplant but no drug. Not ITT analysis as stated
Selective reporting (reporting bias) Low risk Primary outcomes for this review (death, graft loss and acute rejection) have been reported
Other bias High risk Funded by Novartis Pharmaceuticals, 1/5 authors Novartis employee