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. 2017 Jul 21;2017(7):CD006750. doi: 10.1002/14651858.CD006750.pub2

Russ 2003.

Methods
  • Study design: parallel RCT

  • Study duration: recruitment not reported

  • Duration of follow‐up: 6 months

Participants
  • Setting: multicentre (7 centres)

  • Country: Australia

  • Adult recipients of a 1st or 2nd cadaveric or non–HLA identical living donor kidney graft

  • Number: treatment group (33); control group (31)

  • Mean age ± SD (years): treatment group (43.9 ± 12.1); control group (46.9 ± 12.2)

  • Sex (M/F): treatment group (20/13); control group (21/20)

  • Exclusion criteria: PRA > 50%; recipients of re‐grafts who had lost their 1st graft from rejection within the 1st 6 months

Interventions Treatment group
  • SRL trough levels: 10 to 20 ng/mL (to week 4), 10 to 15 ng/mL (weeks 5 to 12), 8 to 15 ng/mL (to 6 months)

  • TAC trough levels: 3 to 7 ng/mL


Control group
  • SRL trough levels: 5 to 10 ng/mL

  • TAC trough levels: 10 to 15 ng/mL (to week 4), 8 to 12 ng/mL (to 6 months)


Both groups
  • SRL within 48 h of transplant

  • Steroids

Outcomes
  • Graft function

  • Incidence of rejection

  • Patient survival at 6 months

  • Graft survival at 6 months

Notes
  • Part of a Global trial published separately

  • Funding source: Wyeth Australia

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Study was described as randomised, method of randomisation was not reported
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 Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No further data reported after 6 months
Selective reporting (reporting bias) Low risk 6 month data was reported as specified in methods
Other bias High risk Funded by Wyeth