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. 2019 Dec 16;2019(12):CD004290. doi: 10.1002/14651858.CD004290.pub3

Fernandes‐Charpiot 2014.

Methods
  • Design: open‐label RCT

  • Duration: not reported

  • Follow up: 12 months

Participants
  • Setting: single centre transplant service

  • Country: Brazil

  • Kidney transplant recipients of extended criteria or standard criteria DD kidneys

  • Number (group 1/group 2): 68 (33/35)

  • Mean age ± SD (years): not reported

  • Sex (M/F): not reported

  • Exclusions: not reported

Interventions Treatment group 1 (EVL/MPS)
  • EVL: doses not reported

  • MPS: doses not reported


Treatment group 2 (TAC/MPS)
  • TAC: doses not reported

  • MPS: doses not reported


Co‐interventions
  • IL2

  • Steroids

Outcomes
  • Death (all causes)

  • Graft loss

  • Acute rejection

  • CMV

Notes
  • Comparison: TOR‐1 versus CNI

  • Abstract only available

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Said to be randomised but no details provided
Allocation concealment (selection bias) Unclear risk Said to be randomised but no information provided
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Primary outcomes unlikely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Insufficient information to permit judgement ‐ abstract only
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement ‐ abstract only
Other bias High risk Novartis Research Support listed in disclosures