Vitko‐201 2001.

Methods	Design: parallel RCT (RAD B201 Study group) Duration: August 1988 to August 1999 Follow up: 3 years
Participants	Setting: multicentre (54 centres) Country: Australia, Austria, Belgium, Czech Republic, France, Germany, Italy, Netherlands, Norway, Russia, South Africa, Switzerland, UK De novo kidney transplant recipients aged 18 to 68 years; LD or DD, ischaemia time < 40 hours Number (group 1/group 2/group 3): 588 ITT population (194/198/196) Mean age ± SD (years): not reported Sex (M/F): not reported Exclusions: multiple organ transplants; +ve T‐cell crossmatch; induction therapy before study entry; hypersensitivity to study drugs; non‐protocol immunosuppressive drugs, treatments, investigational drugs within 1 month before randomisation or baseline; liver disease; HIV; severe cardiac disease; severe uncontrolled hyperlipidaemia
Interventions	Treatment group 1 EVL: initial dose 1.5 mg/d Treatment group 2 EVL: initial dose 3 mg/d Treatment group 3 MMF: 2 g/d Co‐interventions CSA: initial 150 to 400 ng/mL; maintenance 100 to 300 ng/mL Prednisolone
Outcomes	Death (all causes) Graft loss censored for death Graft loss or death with a functioning graft Acute rejection CrCl SCr CMV infection Malignancy Haematological adverse effects Biochemical adverse effects Surgical adverse effects
Notes	Comparison: TOR‐I versus antimetabolite (combine groups 1 & 2) Comparison: low dose versus higher dose TOR‐I
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Patients were randomised according to a computer‐generated schedule that ensured equal distribution among the three treatment groups within each centre
Allocation concealment (selection bias)	Low risk	Patients were randomised according to a computer‐generated schedule that ensured equal distribution among the three treatment groups within each centre
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blind, double dummy for 12 months
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Double‐blind, double dummy for 12 months
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