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

Schaefer 2006.

Methods
  • Design: open‐label RCT

  • Duration: not reported

  • Follow up: 12 months

Participants
  • Setting: single centre

  • Country: USA

  • Primary kidney transplant recipients: DD or non‐HLA identical LD

  • Number (group 1/group 2): 80 (41/39)

  • Mean age ± SD (years): not reported

  • Sex (M/F): not reported

  • Exclusions: not reported

Interventions Treatment group 1
  • SRL: 5mg/d from day 3; target levels 8 to 12 ng/mL


Treatment group 2
  • TAC: 0.15mg/kg/d; target levels 8 to 12 ng/mL


Co‐interventions
  • MMF: 2g/d

  • MP/prednisolone

  • ATG: 4 doses

Outcomes
  • Death (all causes)

  • Graft loss censored for death

  • Acute rejection

  • SCr

  • Infection

  • Biochemical adverse effects

  • Cosmetic/lifestyle adverse effects

Notes
  • Comparison: TOR‐I versus CNI

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Outcomes unlikely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All patients accounted for
Selective reporting (reporting bias) Low risk Prespecified outcomes mentioned
Other bias Unclear risk Insufficient information to permit judgement