Pelletier 2006.

Methods	Study design: parallel RCT Time frame: 1997 to 2002 Follow‐up period: mean 3.7 years Primary endpoints: incidence of acute rejection, chronic rejection and graft loss within 1 year of consent
Participants	Country: USA Setting: single centre First cadaveric or living kidney transplant; > 18 years; MMF > 2 g (unless intolerant) and CsA > 2 mg/kg/d or trough levels > 150 ng/mL Number (randomised/analysed): withdrawal group (60/59); maintenance group (60/59) Mean age ± SD (years): withdrawal group (45 ± 14); maintenance group (45 ± 14) Sex (female): withdrawal group (22%); maintenance group (31%) Donor source (living donors): withdrawal group (36%); maintenance group (37%) Exclusion criteria: SCr > 2.5 mg/dL; previous acute rejection; proteinuria > 600 mg/24 h; presence of steroid treated disease
Interventions	Treatment group Steroid withdrawal at different time points after transplantation (exact time point of steroid withdrawal unclear, but all patients had steroids for > 14 days) Control group Steroid maintenance Baseline immunosuppression Basiliximab (54 patients): day 0 and 4: 20 mg OKT3 (40 patients): day 3 to 5: 5 mg/d Thymoglobulin (6 patients): day 3 to 5 No induction: 14 patients CsA: starts with 5 to 6 mg/kg/d adjusted to trough levels: year 1: 250 ng/mL; thereafter: 150 MMF: 2 g/d Steroids Prednisone: starts with 2 mg/kg, tapered to 0.2 mg/kg at month 1; tapered to 0.15 mg/kg at month 12 Steroid withdrawal: reduced by 2.5 mg/2 wk
Outcomes	Mortality Graft loss Acute rejection SCr (mg/dL) NODAT
Notes	Did not report number screened for eligibility Number of patients discontinued study Withdrawal group: 1 patient Maintenance group: 1 patients withdrawn from study shortly after consent because of proteinuria > 600 mg/24 h and non‐compliance
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Stated 'randomised' but no further information provided.
Allocation concealment (selection bias)	Unclear risk	Not reported
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	Unclear risk	Unclear if ITT analysis performed
Selective reporting (reporting bias)	Low risk	Primary outcomes for this review reported
Other bias	Unclear risk	Funding source not reported Steroids have been withdrawn at different time points after transplantation and the time point of steroid withdrawal is unclear Different induction treatments used, 14% of patients did not receive any induction treatment