Lo 2004.

Methods	Design: parallel RCT Duration: November 2000 to October 2001 Follow up: 6 months
Participants	Setting: unclear Country: USA Kidney transplant recipients (DD) Number (group 1/group 2): 39 (16/23) Mean age (years): group 1 (46); group 2 (49) Sex (M/F): group 1 (10/6); group 2 (13/10) Exclusions: evidence of active infection; those receiving multiple organ transplants; patients with a WBC < 4000/mm3; platelet count ≤ 100,000/mm3; triglycerides ≥ 400 mg/dL; total cholesterol ≥ 300 mg/dL
Interventions	Treatment group 1 SRL: started within 48 hrs of transplant; 4 mg/d for 2 days, then 2 mg/d for levels 5 to 10 ng/mL sTAC: within 48 hrs of transplant to achieve tacrolimus levels 10 to 15 ng/mL Treatment group 2 SRL: started within 48 hours; 10 mg/d for 2 days; 5 mg/d to achieve SRL levels 10 to 15 ng/mL rTAC: dose within 48 hours to achieve levels 5 to 10 ng/mL Co‐interventions ATG Prednisolone
Outcomes	Death (all causes) Cause‐specific death Graft loss censored for death Graft loss or death with a functioning graft Acute rejection SCr CMV infection Malignancy Haematological adverse effects Biochemical adverse effects Surgical adverse effects
Notes	Comparison: variable dose of TOR‐I and CNI The primary endpoint of the study was a composite of patient death, graft lost, or BPAR at 6 months post‐transplantation
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Prospective, randomised, comparative pilot study. No details provided
Allocation concealment (selection bias)	Unclear risk	Prospective, randomised, comparative pilot study. No details provided
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label study
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The primary endpoint of the study was a composite of patient death, graft lost, or biopsy‐confirmed AR at 6 months post‐transplantation; unlikely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) All outcomes	Low risk	All patients completed 6 months of study
Selective reporting (reporting bias)	High risk	Limited information on adverse effects
Other bias	High risk	Sponsored by Wyeth and SangStat