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

Russ 2003.

Methods
  • Design: open‐label RCT (Australian Rapamune‐Tacrolimus Study Group)

  • Duration: not reported

  • Follow up: 6 months

Participants
  • Setting: multicentre (7 centres)

  • Country: Australia

  • Adult kidney transplant recipients; 1st or 2nd DD graft or non‐HLA identical LD

  • Number (group 1/group 2): 64 (33/31)

  • Mean age ± SD (years): group 1 (43.9 ± 12.1); group 2 (46.9 ± 12.2)

  • Sex (MF): group 1 (20/13); group 2 (21/10)

  • Exclusions: sensitized patients with PRA > 50% and recipients of regrafts who had lost their first graft because of rejection within the first 6 months

Interventions Treatment group 1
  • High‐SRL: adjusted for target levels 10 to 15 ng/mL

  • rTAC: adjusted for target levels 3 to 7 ng/mL


Treatment group 2
  • Low‐SRL: adjusted for target levels 5 to 10 ng/mL

  • sTAC: adjusted for target levels 10 to 15 ng/mL


Co‐interventions
  • Prednisolone

Outcomes
  • Death (all causes)

  • Graft loss censored for death

  • Graft loss or death with a functioning graft

  • Acute rejection

  • CrCl

  • SCr

  • Malignancy

Notes
  • Comparison: variable dose of TOR‐I and 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 laboratory based and unlikely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk ITT analysis
Selective reporting (reporting bias) Low risk Prespecified outcomes reported
Other bias High risk Funded by Wyeth