Gonwa‐PSG 2003.

Methods	Design: open‐label RCT Duration: not reported Follow up: 12 months
Participants	Setting: multicentre study (27 centres) Country: USA Kidney transplant recipients > 18 years, DD or non‐HLA identical LRD Number (group 1/group 2): 361 (185/176) Mean age ± SD (years): group 1 (45.3 ± 12.4); group 2 (47.8 ± 12.3) Sex (M/F): group 1 (124/61); group 2 (123/53) Exclusions: non‐heart beating donor or from a HLA identical living donor; extra‐renal solid‐organ transplants or bone‐marrow‐stem cell transplants; known sensitivity to TAC, SRL or MMF; those who were treated with investigational immunosuppressive agents; pregnant; HIV positive
Interventions	Treatment group 1 SRL: initial dose 6 mg within 48 hours of transplant; then 2 mg/d; trough levels 4 to 12 ng/mL Treatment group 2 MMF: 2 g/d Co‐interventions TAC: 0.15 to 0.20 mg/kg/d in 2 divided doses to achieve trough levels of initial 8 to 16 ng/mL; maintenance 5 to 15 ng/mL Prednisolone
Outcomes	Death (all causes) Graft loss censored for death Graft loss or death with a functioning graft BPAR Steroid‐resistant rejection CrCl SCr CMV infection Malignancy Haematological adverse effects Biochemical adverse effects
Notes	Comparison: TOR‐I versus antimetabolite Prograf Study Group
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Patients were randomised 1:1 to receive corticosteroids and either TAC plus SRL or TAC plus MMF. No other information
Allocation concealment (selection bias)	Unclear risk	Patients were randomised 1:1 to receive corticosteroids and either TAC plus SRL or TAC plus MMF. No other information
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 death, 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)	High risk	Limited information on adverse effects. No information on wound complications
Other bias	High risk	Sponsored by Fujisawa