ATLAS 2003.

Methods	Multicentre (21) parallel‐RCT Duration: NS Stratified by centre
Participants	Countries: Poland, Czech Republic, Finland, Sweden First cadaveric (87%) or living donor kidney transplant Mean age (± SD) Treatment group: 43.2 ± 11.4 Control group 1: 43.2 ± 12.8 Control group 2: 43.9 ± 12.1 Number (treatment/control 1/control 2): 457 randomised, 451 analysed (153/151/147) Sex (% male) Treatment group: 62.1% Control group 1: 61.2% Control group 2: 65.6% Exclusions: PRA ≥ 50% in previous 6 months; any organ transplant or kidney re transplant; ongoing immunosuppressive therapy; pregnancy or breast feeding; allergy or intolerance to study medication; HIV infection; significant liver disease; current or history of malignancy; significant uncontrolled infection; severe diarrhoea, vomiting or active peptic ulcer; NHBD
Interventions	Treatment group Basiliximab: 2 mg days 0 and 4 Control group 1 MMF: 2 g/d for up to 14 days then 1 g/d Control group 2 MMF: 2 g/d for up to 14 days then 1 g/d Steroids: 125 mg IV day 1 then orally 20 mg/d (days 2‐14), 15 mg/d (days 15‐28) 10 mg/d (days 29‐42) and 5 mg/d thereafter Baseline immunosuppression TAC: Initial dose 0.2 mg/kg/d then adjusted for trough levels of 10‐20 ng/mL (days 0‐28) then 5‐15 ng/mL thereafter Steroids: all patients received 500 mg IV on day 0
Outcomes	Mortality Graft loss Acute rejection CMV
Notes	6 month follow‐up
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“the randomisation list was generated by the Data Operations department” "stratified by centre”
Allocation concealment (selection bias)	Low risk	“each centre received a unique sequence of patient numbers and a set of sealed envelopes” ”the corresponding envelopes were opened providing the information for the allocated treatment”
Blinding (performance bias and detection bias) Objective outcomes	High risk	Open‐label, blinding of outcome assessors not stated
Blinding (performance bias and detection bias) Subjective outcomes	High risk	Open‐label, blinding of outcome assessors not stated
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis reported, all patients followed up or accounted for. 6/457 excluded ‐ never received transplant or study drug ‐ unlikely to affect results
Selective reporting (reporting bias)	Low risk	Primary outcomes for this review (death, graft loss and acute rejection) have been reported
Other bias	High risk	Sponsored by a grant from Fujisawa GmbH