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

Cattaneo 2005.

Methods
  • Design: parallel RCT

  • Duration: not reported

  • Follow up: 12 months

Participants
  • Setting: single centre

  • Country: Italy

  • Primary kidney transplant recipients

  • Number (group 1/group 2): 21 (11/10)

  • Mean age ± SD (years): group 1 (47.5 ± 16.0); group 2 (42.3 ± 13.2)

  • Sex (M/F): group 1 (7/4); group 2 (5/5)

  • Exclusions: unclear

Interventions Treatment group 1
  • SRL: 4 mg and then adjusted to level 5 to 10 ng/mL


Treatment group 2
  • CSA: 1 to 2 mg/kg/d and adjusted to initial level 120 to 220 ng/mL; maintenance 70 to 120 ng/mL


Co‐interventions
  • MMF: 1g/d

  • Alemtuzumab: 30 mg

  • MP: 200 mg IV intraoperatively

  • Prednisolone: 250 mg on day 1, 125 mg on day 2

Outcomes
  • Death (all causes)

  • Graft loss censored for death

  • Graft loss or death with functioning graft

  • Acute rejection

  • CrCl

  • Infection

  • CMV

  • Biochemical adverse effect

  • Surgical adverse effect

  • Cosmetic/lifestyle adverse effect

Notes
  • Comparison: TORI versus CNI

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "They were allocated to one of the following two study groups according to a randomization design"
Allocation concealment (selection bias) Unclear risk Quote: "They were allocated to one of the following two study groups according to a randomization design"
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 MPA levels & these unlikely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Unclear whether all patients randomised were included in analyses
Selective reporting (reporting bias) High risk Only GFR and SCr reported
Other bias Unclear risk No report on funding