Tedesco‐Silva 2003.

Methods	Design: open‐label RCT Duration: January 2000 to January 2002 Follow up: 12 months
Participants	Setting: single centre Country: Brazil Kidney transplant recipients of Black ethnicity; ≥ 13 years; DD or non HLA identical LD; ‐ve T‐cell crossmatch; WBC ≥ 4 x 109/L, platelet count ≥ 100 x 109/L; fasting cholesterol ≤ 350 mg/dL; triglycerides ≤ 500 mg/dL Number (group 1/group 2): 70 (34/36) Mean age ± SD (years): group 1 (33.1 ± 10.9); group 2 (35.6 ± 12.3) Sex (M/F): group 1 (22/12); group 2 (25/9) Exclusions: evidence of systemic infection; a history of clinically significant cardiac abnormalities or malignancy within 10 years of enrolment into the study; PRA ≥ 50%; immunosuppression; antibody induction; recent investigational drug; HbSAg +ve
Interventions	Treatment group 1 SRL: 15 mg then 5 mg/d till day 7; adjusted to levels 8 to 12 ng/mL Treatment group 2 SRL: 15 mg then 5 mg/d till day 7; adjusted to levels 15 to 20 ng/mL Co‐interventions CSA: 8 to 10 mg/kg for trough levels 200 to 300 ng/mL for 2 weeks; 100 to 200 ng/mL for 2 weeks; then 100 to 150 ng/mL Prednisolone
Outcomes	Death (all causes) Cause‐specific death Graft loss censored for death Graft loss or death with a functioning graft Acute rejection Steroid‐resistant rejection CrCl SCr Infection CMV infection Malignancy Haematological adverse effects Biochemical adverse effects Surgical adverse effects Cosmetic/life style adverse effects
Notes	Comparison: low dose versus higher dose TOR‐I
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Prospective, 12‐month, randomised, two‐arm, concentration‐controlled study. Randomised 7 days after transplant
Allocation concealment (selection bias)	Unclear risk	Prospective, 12‐month, randomised, two‐arm, concentration‐controlled study
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label study
Blinding of outcome assessment (detection bias) All outcomes	Low risk	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	Expected outcomes reported
Other bias	Unclear risk	Insufficient information to permit judgement