CALFREE 2006.

Methods	Design: open‐label RCT Duration: January 2001 to July 2004 Follow up: 6 months
Participants	Setting: single centre Country: Switzerland Kidney transplant recipients aged 15 to 75 years Number (group 1/group 2): 127 (63/64) Mean age ± SD (years): group 1 (48 ± 14.4); group 2 (49.5 ± 14.4) Sex (M/F): group 1 (44/19); group 2 (41/23) Exclusions: HLA identical grafts; high immunological risk; positive cross match or ABO incompatibility; graft from a donor > 68 years; cold ischaemia time > 36 hours
Interventions	Treatment group 1 SRL: 30 mg/d on days 0, 1, 2. Then 16 mg/d for trough level 10 to 2 0ng/mL (M1 to 3) then trough levels of 8 to 15 ng/mL (M4 to 6) Treatment group 2 CSA: initial dose 600 mg/d for trough level 250 to 300 ng/mL for 3 months and then 150 to 250 ng/mL Co‐interventions MMF: 2 g/d MP or prednisolone: initial dose 0.5 mg/kg, maintenance 5 mg/day stopped at 6 months
Outcomes	Kidney function Adverse events Rejection
Notes	Comparison: TOR‐I versus CNI
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote "127 patients were randomly assigned before transplant..(in a masked fashion)"
Allocation concealment (selection bias)	Unclear risk	Quote: "127 patients were randomly assigned before transplant..(in a masked fashion)"
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 (kidney function) was laboratory based and unlikely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) All outcomes	Low risk	4/127 (3%) did not complete follow up
Selective reporting (reporting bias)	Low risk	Expected outcomes (graft function, rejection, death, adverse effects) reported
Other bias	High risk	Sponsored by Wyeth