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

Hanaway 2008.

Methods
  • RCT

Participants
  • Setting: NS

  • Country: USA

  • Randomised and transplanted based on risk profile

    • High risk (HR): African‐Americans; PRA ≥ 20%; re‐transplant

    • Low risk (LR): non‐African‐Americans; PRA < 20%, primary transplant

  • Age: Adults

  • Number (Bas‐LR/CIH‐LR/CIH‐HR/Thymo‐HR): 474 (171/164/70/69)

Interventions Treatment group
  • Basiliximab: 2 doses (20 mg) days 0‐4


Control group (CIH‐LR/CIH‐HR/Thymo‐HR)
  • Other antibodies (HR and LR patients given alemtuzumab)

    • Alemtuzumab (CIH): 30 mg, day 0

    • Thymoglobulin: 15 mg/kg/d, days 0‐4


Baseline immunosuppression
  • TAC: NS

  • MMF: NS

  • Steroids: 1 g prior to discharge

Outcomes
  • Mortality

  • Graft loss

  • Acute rejection

  • Delayed graft function

  • Infection/CMV

  • Malignancy

Notes
  • Groups 2 and 3 and 4 combined for comparison IL2R versus other antibody

  • 1 year follow‐up

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Stated "randomized" no further information provided
Allocation concealment (selection bias) Unclear risk Not stated
Blinding (performance bias and detection bias) 
 Objective outcomes Unclear risk Not stated
Blinding (performance bias and detection bias) 
 Subjective outcomes Unclear risk Not stated
Incomplete outcome data (attrition bias) 
 All outcomes High risk All patient numbers listed under parameters in results table, however dichotomous results presented as percentages and no SD for continuous outcomes
Selective reporting (reporting bias) High risk Primary outcomes only reported as percentages
Other bias High risk Funding source not stated, 1 author employee of the pharmaceutical company Astellas Pharma U.S. Abstract only data available