Takahashi 2013a.

Methods	Study design: parallel RCT Study duration: recruitment February 2008 to August 2010 Duration of follow‐up: 12 months
Participants	Setting: multicentre Country: Japan Patients aged 18 to 65 years undergoing primary kidney transplantation Number: treatment group (61); control group (61) Mean age ± SD (years): treatment group (42.5 ± 14.13); control group (38.6 ± 11.36) Sex (M/F): treatment group (46/15); control group (37/24) Exclusion criteria: no evidence of graft function within 24 hours of transplantation; cold ischaemia time > 24 h; donor age > 65 years; patients of multiorgan, ABO‐incompatible, positive T‐cell cross‐match or HLA identical living‐related‐donor transplants; PRA > 20%
Interventions	Treatment group CsA trough levels: 100 to 200 ng/mL (months 0 to 2), 75 to 150 ng/mL (months 2 and 3), 50 to 100 ng/mL (months 4 and 5), 25 to 50 ng/mL thereafter EVL trough levels: 3 to 8 ng/mL (from day 5) Control group CsA trough levels: 200 to 300 ng/mL (months 0 to 2), 100 to 250 ng/mL thereafter MMF: 2 g/d Both groups Basiliximab induction PRED: as per local protocol, minimum dose of 5 mg/d at 12 months
Outcomes	Efficacy failure: defined as the composite of treated BPAR, graft loss, death or loss to follow‐up at 12 months Composite of graft loss, death or long‐term follow‐up at 12 months
Notes	Funding source: "This study was supported by Novartis Pharma K.K. Japan. The authors thank Heike Schwende, PhD, Novartis Pharma AG Switzerland, for organizing the development of the manuscript. They also thank Swati Machwe, PhD, and Raghuraj Puthige, PhD, Novartis Healthcare Pvt. Ltd India for editorial assistance."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Independent validated system that automated the random assignment of treatment arms
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label study
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Most outcomes were objective, however there was no blinding of assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis all patients analysed
Selective reporting (reporting bias)	Low risk	Prespecified outcomes were reported
Other bias	High risk	Funded by Novartis who also helped in manuscript development