CAESAR Study 2007.

Methods	Study design: 3‐arm, parallel RCT (1:1:1) Study duration: recruitment 12 January 2001 to 24 October 2002 Duration of follow‐up: 1 year
Participants	Setting: international, multicentre (32 centres) Countries: Australia, Europe and North America Patients of low‐to‐moderate immunologic risk who had received their 1st kidney transplant Number: treatment group 1 (179); treatment group 2 (184); control group (173) Mean age, range (years): treatment group 1 (47.2, 19 to 78); treatment group 2 (47.6, 20 to 77); control group (48.7, 21 to 73) Sex (males): treatment group 1 (60%); treatment group 2 (65%); control group (65%) Exclusion criteria: HLA‐identical living‐related donor recipients; patients anticipated to require ALG preparations for DGF
Interventions	Treatment group 1 Daclizumab induction MMF: maintenance dose of at least 1.5 g/d Steroids CsA withdrawal trough levels: 50 to 100 ng/mL (months 1 to 3), at month 4, CsA decreased by 33% every month, until it was completely withdrawn at month 6 Treatment group 2 Daclizumab induction MMF Steroids Low‐dose CsA trough levels: 50 to 100 ng/mL for 12 months Control group MMF Steroids Standard‐dose CsA: target trough level 150 to 300 ng/mL from baseline through to month 4 and 100 to 200 ng/mL thereafter
Outcomes	Kidney function at 3 and 12 months (GFR) Patient survival Graft survival Calculated CrCl at 12 months SCr at 12 months BPAR at 6 and 12 months
Notes	Unless medically contraindicated, all rejection episodes were BPAR Funding source: "Thanks to Elizabeth Calleja of Roche USA for her critique and Iain Bartlett for his editorial assistance... Funding for this study was provided by F. Hoffmann‐La Roche Ltd., Basel, Switzerland"
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The randomisation code for the CAESAR study (M67005) was generated in the Oracle Clinical randomisation module, Each site was supplied with a list of unique patient numbers
Allocation concealment (selection bias)	Low risk	Treatment assignment, corresponding to patient number, was provided on a sheet sealed inside a randomisation envelope
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label study
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information to permit judgement
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis and had minimal missing data
Selective reporting (reporting bias)	Low risk	The report include all possible outcomes
Other bias	High risk	Funded by Roche, Switzerland