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

EVEROLD 2014.

Methods
  • Design: open‐label RCT

  • Duration: not reported

  • Follow up: 1 year

Participants
  • Setting: national multi‐centre study

  • Country: France

  • Participants: 1st or 2nd single transplantation of a recipient > 60 years, donor > 60 years, low immunological risk (PRA < 30%)

  • Number: 304 enrolled; 285 analysed

  • Mean age ± SD (years): not reported

  • Sex (M/F): not reported

  • Exclusions: LD; 3rd transplantation; PRA > 30%

Interventions Treatment group 1
  • CSA: 6 to 8 mg/kg/d adjusted for C2 levels

  • MMF: 3 g/d

  • IL2 induction


Treatment group 2
  • EVL: 4 to 6 mg/d from day 5

  • MMF: 3 g/d

  • ATG induction


Treatment group 3
  • Switch to EVL at week 7

  • CSA till end of week 6

  • IL2 induction

  • MMF


Co‐interventions
  • Steroids

Outcomes
  • Patient survival

  • Graft loss

  • DGF

  • BPAR

  • GFR (MDRD)

  • Discontinuation

  • Adverse events

Notes
  • M‐TOR versus CNI (compared groups 1 and 2)

  • No information on numbers in each group so data could not be entered into meta‐analyses

  • No response from email to authors

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Said to be randomised but no other information provided.
Allocation concealment (selection bias) Unclear risk Said to be randomised but no other 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 Low risk Reported on 94% of participants.
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement ‐ abstract only
Other bias High risk Novartis, Roche, Genzyme listed on clinical trials as sponsors