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

Gallon 2006.

Methods

  • Design: open‐label RCT

  • Duration: October 2000 to September 2001

  • Follow up: mean of 8.6 years
Participants

  • Setting: single centre transplant service

  • Country: USA

  • Kidney transplant recipients aged 30 to 70 years

  • Number (group 1/group 2): 90 (46/44); analysis on only 82 (37/45) patients

  • Mean age ± SD (years): group 1 (46.3 ± 12.6); group 2 (42.3 ± 11.9)

  • Sex (M/F): group 1 (22/15); group 2 (28/17)

  • Exclusions: paediatric recipients; receiving ABO incompatible or a positive donor‐recipient cross match kidney; multi‐organ transplants; kidney from a non‐heart beating donor; known sensitivity to TAC, SRL or MMF; pregnant; HIV positive
Interventions Treatment group 1

  • SRL: started on postoperative day 1 at 3 mg/d; target 24‐h trough levels 7 to 10 ng/mL


Treatment group 2

  • MMF: started on postoperative day 1 at 2 g/d


Co‐interventions

  • TAC: levels 8 to 10 ng/mL to 3 months; 7 to 9 ng/mL to 6 months; 6 to 8 ng/mL thereafter

  • Basiliximab

  • MP: till day 2
Outcomes

  • Death (all causes)

  • Graft loss censored for death

  • Graft loss or death with a functioning graft

  • Acute rejection

  • CrCl
Notes

  • Comparison: TOR‐I versus antimetabolite

  • The primary efficacy end‐point was the 3‐year graft survival rates. Outcome data also available for 8.6 years follow‐up
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Said to be randomised but no information provided
Allocation concealment (selection bias) Unclear risk Said to be randomised but no information provided
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 graft loss by 3 years & unlikely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) 
 All outcomes High risk 82/94 (87%) randomised were analysed ‐ per protocol analysis only
Selective reporting (reporting bias) High risk Limited information on adverse effects
Other bias High risk Partly funded by Astellas‐USA