Kramer‐2307 2003.

Methods	Design: open‐label RCT (RAD 2307 International Study Group) Duration: not reported Follow up: 12 months with 24 month extension (203 of 256 enrolled for second year)
Participants	Setting: multicentre study Countries: Australia, Colombia, Germany, France, Czech Republic, Argentina, USA, Italy, Norway, Switzerland Adult de novo kidney transplant recipients (DD, LD) Number (group 1/group 2): 256 (117/139); 243 non‐Black recipients randomised Mean age ± SD (years): group 1 (43.9 ± 12.7); group 2 (46.3 ± 11.8) Sex (M/F): group 1 (81/36); group 2 (87/52) Exclusions: HLA matched LD recipient
Interventions	Treatment group 1 EVL: initial dose 1.5 mg/d for trough levels ≥ 3 ng/mL Treatment group 2 EVL: initial dose 3 mg/d for trough levels ≥ 3 ng/mL Co‐interventions Basiliximab CSA: initial C2 levels 500 to 700 ng/mL (0 to 8 weeks); C2 levels 350 to 450 ng/mL week 9 to month 12. Prednisolone
Outcomes	Death (all causes) Graft loss censored for death Graft loss or death with a functioning graft Acute rejection eGFR (Nankivell formula) SCr CMV infection Malignancy Haematological adverse effects Biochemical adverse effects Surgical adverse effects Cosmetic/life style adverse effects
Notes	All 13 Black recipients received 3 mg/day of everolimus but were included in analyses 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, multicenter, randomised study. No other information provided
Allocation concealment (selection bias)	Unclear risk	Prospective, multicenter, randomised study. No other information 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	Primary endpoint was GFR and creatinine measured in central laboratory. 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	High risk	Supported by Novartis Pharma AG