Grinyo 2004.

Methods	Design: open‐label RCT Duration: 7 December 2000 to 21 January 2002 Follow up: 2 years
Participants	Setting: multicentre study (7 centres) Country: Spain Kidney transplant recipients aged 9 to 65 years Number (group 1/group 2): 87 (43/44) Mean age ± SD (years): group 1 (47.4 ± 11.2); group 2 (45.2 ± 13.5) Sex (M/F): group 1 (30/13); group 2 (31/13) Exclusions: infection with HIV; PRA > 50%; donors younger < 9 or > 65 years; cold Ischaemic time >36 hours; non heart‐beating donors; infection with either HBV or HCV with impairment in liver function tests
Interventions	Treatment group 1 Low dose‐SRL: 6 mg on day 1 and then 2 mg/d to achieve trough levels 4 to 8 ng/mL sTAC: 0.1 mg/d for trough levels 8 to 12 ng/mL for 3 months then 5 to 10 ng/mL Treatment group 2 High‐dose SRL: 15 mg on day 1 and then 5 mg/d to achieve levels 8 to 16 ng/mL rTAC: 0.05 mg/kg/d for levels 3 to 8 ng/mL; TAC withdrawn from 4 months onwards in patients with stable kidney function, no rejection in previous 3 weeks & stable SRL levels Co‐interventions Prednisolone
Outcomes	Death (all causes) Cause‐specific death Graft loss censored for death Graft loss or death with a functioning graft Acute rejection CrCl (primary outcome) SCr Haematological adverse effects Biochemical adverse effects Cosmetic/life style adverse effects
Notes	Comparison: variable dose of TOR‐I and CNI
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Patients were randomly allocated in a 1:1 proportion to one of two groups using computer‐generated randomisation envelopes prepared by Wyeth without stratification
Allocation concealment (selection bias)	Low risk	Patients were randomly allocated in a 1:1 proportion to one of two groups using computer‐generated randomisation envelopes prepared by Wyeth without stratification
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 outcome was kidney function: Laboratory outcome 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	No information on wound complications & limited information on other adverse effects
Other bias	High risk	Assistance provided by Wyeth