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. 2014 Nov 24;2014(11):CD010699. doi: 10.1002/14651858.CD010699.pub2

CTOT‐10 Study 2013.

Methods
  • Study design: parallel RCT

  • Study duration: NS

  • Mean duration of follow‐up: 40 weeks

Participants
  • Country: USA

  • Setting: phase II, multi‐centre study

  • First living or standard‐donor criteria kidney recipients; aged 18 to 65 y

  • PRA: < 30%

  • Epstein Barr virus seronegative: none

  • Number: group 1 (6); group 2 (6); group 3 (7)

  • Age: NS

  • Sex (M/F): NS

  • Exclusion criteria: extended‐criteria donor kidneys

Interventions Group 1 (control)
  • Alemtuzumab induction, tacrolimus maintenance


Group 2
  • Alemtuzumab induction, belatacept maintenance


Group 3
  • Basiliximab induction, 3 months taper of tacrolimus, belatacept maintenance


Co‐interventions (all groups)
  • Short‐term prednisone and maintenance mycophenolate mofetil 1g twice daily

Outcomes
  • Primary outcome: incidence of adverse events and serious adverse events

Notes
  • Sponsored by National Institute of Allergy and Infectious Diseases

  • Halted prematurely (mean 40 weeks follow‐up) because four recipients had vascular thrombosis, three lost their grafts and there was a high incidence of acute rejection

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described in abstracts
Allocation concealment (selection bias) Unclear risk Not described in abstracts
Blinding (performance bias and detection bias) 
 All outcomes Low risk Open label
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Outcomes for all enrolled patients described in detail at time of study termination
Selective reporting (reporting bias) Low risk Adverse events reported fully in keeping with primary outcomes stated in protocol, though only in abstract form
Other bias Unclear risk Insufficient data published for reliable judgment