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

de Boccardo 2002.

Methods
  • Placebo‐controlled RCT

Participants
  • Setting: International Multicentre (31)

  • Countries: Argentina, Brazil, Costa Rica, Chile, Mexico

  • Cadaveric (46%) or living donor kidney transplant

  • Agee: 38.0 ± 12.4 years

  • Number (treatment/control): 310 (NS/NS)

  • Sex (% M/F): 58.6/40.4

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


Control group
  • Placebo


Baseline immunosuppression
  • CSA: 10 mg/kg/d (day 0) and dose adjusted to predefine trough levels

  • AZA: 1‐2 mg/kg/d

  • Steroids: As per site standards, minimum daily dose of 5 mg at 6 months

Outcomes
  • Mortality

  • Graft loss

  • Acute rejection

  • Malignancy

Notes
  • Number randomised in each group NS, calculated from given proportions

  • 6 month follow‐up

  • Trial on‐going

  • Data from abstract only

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Stated "randomised", no further information provided
Allocation concealment (selection bias) Unclear risk Not stated
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 Unclear risk "Double blind", blinding of outcome assessors not stated
Incomplete outcome data (attrition bias) 
 All outcomes High risk Stated ITT, but not all randomised patients were analysed. Data only available from conference proceedings abstract
Selective reporting (reporting bias) Unclear risk Primary outcomes for this review (death, graft loss and acute rejection) have been reported, however data only available as percentages from conference proceedings abstract
Other bias Unclear risk Funding source not stated, data only available from conference proceedings abstract