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

Favi 2009.

Methods
  • Design: open‐label RCT

  • Duration: May 2004 to August 2006

  • Follow up: 3 years

Participants
  • Setting: single centre transplant unit

  • Country: Italy

  • Recipients of DD transplants

  • Number (group 1/group 2): 60 (30/30)

  • Mean age ± SD (years): group 1 (44 ± 11); group 2 (45 ± 10)

  • Sex (M/F): group 1 (15/15); group 2 (18/12)

  • Exclusions: PRA > 50%; cold ischaemia time > 24 hours

Interventions Treatment group 1 (EVL/sCSA)
  • EVL; start dose 0.75 mg twice/d then dosed to maintain a trough level of 3 to 12 ng/mL

  • CSA: start dose 400 mg twice/d and then dosed to maintain a C2 level of 350 to 700 ng/mL


Treatment group 2 (MMF/sTAC)
  • TAC: dosed to maintain a trough level of 8 to 10 ng/mL by month 3 and 5 to 8 ng/mL thereafter

  • MMF: 1 g twice daily


Co‐interventions
  • Basiliximab

  • Corticosteroids

Outcomes
  • Death (all causes)

  • Graft loss censored for death

  • Graft loss or death with a functioning graft

  • BPAR

  • CrCl

  • Biochemical adverse effects

Notes
  • Comparison: TOR‐I versus antimetabolite

  • CSA and TAC were considered comparable across the groups as CNI

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: "consecutively assigned 1:1 to one of the two immunosuppressive regimens"
Allocation concealment (selection bias) High risk Quote: "consecutively assigned 1:1 to one of the two immunosuppressive regimens"
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 outcome was laboratory based and unlikely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All patients completed follow‐up
Selective reporting (reporting bias) High risk Adverse effects incompletely reported
Other bias Low risk This study was partially supported by UCSC grant MIUR 2007