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

FIBRASIC 2009.

Methods
  • Design: open‐label RCT

  • Duration: not reported

  • Follow up: 12 months

Participants
  • Setting: multicentre (4 centres)

  • Country: Belgium

  • De novo Kidney transplant recipients

  • Number (group 1/group 2): 45 (24/21)

  • Mean age ± SD (years): not reported

  • Sex (M/F): not reported

  • Exclusions: not reported

Interventions Treatment group 1 (SRL/MMF)
  • SRL: doses not reported

  • MMF: doses not reported


Treatment group 2 (CSA/MMF)
  • CSA: doses not reported

  • MMF: doses not reported


Co‐interventions
  • IL2

  • Steroids

Outcomes
  • GFR

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 a RCT but no details provided.
Allocation concealment (selection bias) Unclear risk Said to be a RCT but no details provided
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement ‐ abstract only
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 Unclear risk Insufficient information to permit judgement ‐ abstract only