Sampaio 2008.

Methods	Design: open‐label RCT Duration: 12 August 2003 to 04 March 2005 Mean follow‐up: 12 months
Participants	Setting: single centre Country: Brazil Participants: first kidney allograft, DD or LRD Number (group 1/group 2): 100 (50/50) Mean age ± SD (years): group 1 (42.6 ± 14.2); group 2 (37.4 ± 10.3) Sex (M/F): group 1 (38/12); group 2 (31/19) Exclusions: recipients of a kidney from non‐heart beating or ABO incompatible donors or with a positive crossmatch
Interventions	Treatment group 1 MMF: 2 g/d sTAC: 0.1 to 0.15 mg/ kg/d with levels 15 to 20 ng/mL (day 0 to 15); 10 to 15 ng/mL (days 15 to 30); 8 to 12 ng/mL (days 30 to 90); 5 to 10 ng/mL (> 90 days) Treatment group 2 (SRL/sTAC) SRL: 15 mg stat, 5 mg/d to day 7 and then 2 mg/d first year sTAC: 0.1 to 0.15 mg/ kg/d with levels 15 to 20 ng/mL (day 0 to 15); 10 to 15 ng/mL (days 15 to 30); 8 to 12 ng/mL (days 30 to 90); 5 to 10 ng/mL (> 90 days) Co‐interventions Corticosteroids Pneumocystis prophylaxis No induction therapy
Outcomes	Composite end point ‐ first occurrence of BPAR, graft loss, death Incidence of BPAR, severity of AR Use of ATG graft loss, death and patient and graft survival censored for death Safety outcomes: infections, malignancy, diabetes, hypercholesterolaemia Kidney function: Cockcroft‐Gault formulae
Notes	Comparison: TOR‐1 versus MMF
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "randomised 1:1 using a computer generated sequence number"
Allocation concealment (selection bias)	Unclear risk	Randomisation was computer generated but unclear whether sequence was known to investigators
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 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 studies pre‐specified outcomes mentioned
Other bias	High risk	Grant sponsored by Jansen‐Cilag