Morelon 2010.

Methods	Design: RCT Duration: not reported Mean follow‐up: 12 months
Participants	Setting: single centre Country: France Kidney transplant recipients aged 18 to 65 years; PRA < 20%; negative cross‐match; WBC > 4; platelets > 150; triglyceride < 4.5 mmol/L; cold ischaemia < 24 hours Number (group 1/group 2): 19 (9/10) Mean age ± SD (years): group 1 (42.6 ± 8.8); group 2 (51.1± 8.2) Sex (M/F): group 1 (5/4); group 2 (1/9) Exclusions: multiorgan transplant; previous malignancy; positive for HIV, HBV, HCV; infection at transplant; previous immunosuppression
Interventions	Treatment group 1 SRL 15 mg/d on days 0 and 1; 10 mg/d on day 2; 5 mg/d on day 3 for levels 10 to 15 ng/mL MMF: 2 g/d Treatment group 2 (CSA) CSA: 5 mg/kg for target 125 to 225 ng/mL MMF: 2g/d Co‐interventions Prednisone
Outcomes	Death (all causes) Acute rejection Graft loss Adverse effects T cell parameters
Notes	Comparison: SRL versus CSA
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomised using sealed envelopes
Allocation concealment (selection bias)	Low risk	Randomised using sealed envelopes
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 of death/graft loss/AR 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	not all prespecified outcomes mentioned, limited information on adverse events
Other bias	High risk	Funded by Genzyme