ATLAS Study 2005.

Methods	Study design: parallel RCT Time frame: not reported, but before 2005 Follow‐up period: 3 years Primary endpoint: incidence of and time to first biopsy‐proven acute rejection within 6 months after transplantation
Participants	Country: 10 European countries Setting: multicentre (21 centres) First cadaveric or living kidney transplant; aged 18 to 65 years Number (randomised/analysed): withdrawal group (152/147); maintenance group (151/151) Mean age ± SD (years): withdrawal group (44 ± 12); maintenance group (43 ± 13) Sex (female): withdrawal group (35%); maintenance group (40%) Donor source (living donor): withdrawal group (13%); maintenance group (12%) Exclusion criteria: PRA ≥ 50% in previous 6 months; previous organ transplant; non‐heart beating kidney donor; requiring any other immunosuppression; HIV infection; uncontrolled infection; significant liver disease; malignancy; severe diarrhoea; vomiting; active peptic ulcer
Interventions	Treatment group Steroid withdrawal day 1 after transplantation Control group Steroid maintenance Baseline immunosuppression TAC: started within 12 hours before transplantation with 0.2 mg/kg divided in two doses, adjusted to trough levels day 28: 10 to 20 ng/mL, thereafter: 5 to 15 ng/mL MMF: day 0: 1000 mg, day 1 to 14: 2000 mg, thereafter: 1000 mg Steroids IV methylprednisone: day 0: 500 mg or less Withdrawal group: no further steroids Maintenance group: IV methylprednisone day 1: 125 mg, or prednisone day 2 to 14: 20 mg; day 15 to 28: 15 mg; day 29 to 42: 10 mg; thereafter: 5 mg
Outcomes	Mortality Graft loss Biopsy‐proven acute rejection NODAT Infection CMV infection Malignancy Cardiovascular events SCr (µM) CrCl (mL/min)
Notes	This study had a third arm with basiliximab induction followed by TAC monotherapy (154 patients) Did not report number screened for eligibility Number of patients excluded from analysis Withdrawal group: 1 (either did not receive study drug or did not undergo transplantation) Maintenance group: 4 (either did not receive study drug or did not undergo transplantation) Number of patients discontinued study Withdrawal group: 8 (primarily because of protocol violation) within the first year Maintenance group: 13 (primarily because of protocol violation) within the first year 3‐year follow‐up: data of 278 patients available (139/139)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Stated 'Randomization was performed with a 1:1 ratio stratified by centre. The randomization list was generated by the Data Operation Department of Fujisawa GmbH. Each centre received a unique sequence of patient numbers and a set of sealed envelopes.'
Allocation concealment (selection bias)	Low risk	Stated 'sealed envelopes'
Blinding (performance bias and detection bias) All outcomes	High risk	Open‐label
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Outcomes are objective hard endpoints
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis performed; all patients followed up or accounted for
Selective reporting (reporting bias)	Low risk	Primary outcomes for this review have been reported
Other bias	High risk	Sponsored by a grant from Fujisawa GmbH The investigator‐initiated 1‐year follow‐up was supported by an unrestricted grant from Astellas, Munich, Germany