Durrbach 2008.

Methods	Design: open‐label RCT Duration: 2002 to 2004 Follow up: 6 months
Participants	Setting: multicentre pilot study Country: France Kidney transplant recipients of extended criteria donors Number (group 1/group 2): 72 randomised; 69 transplanted (33/36) Mean age ± SD (years): group 1 (52.6 ± 11.2); group 2 (57.1 ± 8.9) Sex (M/F): not reported Exclusions: positive crossmatch; peak PRA > 50%; dual kidney allograft; donation after cardiac death
Interventions	Treatment group 1 SRL: 15 mg in first 2 days post transplant & 10 mg daily for initial target 10 to 20 ng/mL; maintenance 10 to 20 ng/mL Treatment group 2 CSA: 6 mg/kg/d for initial target 150 to 300 ng/mL at 3 months; 75 to 200 ng/mL at 6 months Baseline immunosuppression Steroids (prednisone or prednisolone) MMF ATG
Outcomes	Death (all causes) Graft loss censored for death Graft loss or death with a functioning graft Acute rejection SCr
Notes	Comparison: TOR‐I versus CNI
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Centrally randomised
Allocation concealment (selection bias)	Low risk	Centrally randomised
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 outcomes were patient/graft survival and these 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	All prespecified primary outcomes reported
Other bias	High risk	Funded by Wyeth. EUDRACT trial number: 0468E1‐100969