Montagnino 2005.

Methods	Study design: parallel RCT Time frame: not reported, but before 2005 Follow‐up period: 3 years Primary endpoint: graft survival
Participants	Country: Italy Setting: multicentre (number of centres not reported) First and second cadaveric or living kidney transplant; 18 to 65 years Number (randomised/analysed): withdrawal group (65/65); maintenance group (68/68) Mean age ± SD (years): withdrawal group (44 ± 10); maintenance group (46 ± 12) Sex (female): withdrawal group (31%); maintenance group (38%) Donor source (living donors): withdrawal group (5%); maintenance group (6%) Exclusion criteria: ischaemia time > 40 hours; PRA > 50%
Interventions	Treatment group Steroid withdrawal 7 days after transplantation Control group Steroid maintenance Baseline immunosuppression Basiliximab: days 0 and 4: 20 mg CsA: twice daily 3 to 5 mg/kg adjusted to trough levels; week 1 to 4: 150 to 300 ng/mL; month 2 to 6: 100 to 250 ng/mL; thereafter: 100 to 200ng/mL Amendment to study protocol after availability of new evidence: CsA levels < 100 ng/mL EVL: 1.5 mg twice daily Steroids Withdrawal group: prednisone: day 1 to 5: 20 mg/d; day 6: 5 mg; day 7: 5 mg; then stopped Maintenance group: prednisone: week 1 to 2: 20 mg/d; week 3 to 4: 15 mg/d; week 5 to 6: 10 mg/d; week 7 to month 12: 5 to 10 mg/day; thereafter: 2.5 to 5 mg/d
Outcomes	Mortality Graft loss Biopsy‐proven acute rejection NODAT Malignancy Infection CMV infection SCr (mg/dL) CrCl (mL/min)
Notes	Did not report number screened for eligibility Number of patients discontinued treatment Withdrawal group: reintroduced steroids (28) Contact with study authors for additional information: authors contacted 2 September 2013; no response received
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Centralised randomisation by a randomisation list, stratified within centres using an interactive voice‐response system
Allocation concealment (selection bias)	Low risk	'The sequence was concealed until interventions were assigned.'
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	All patients followed up or accounted for; ITT analysis performed ('All the analyses considered all the randomised patients, grouped originally by randomised treatment as per ITT concept.')
Selective reporting (reporting bias)	Low risk	Primary outcomes for this review reported
Other bias	High risk	Supported by grant from Novartis