Sola 2002.

Methods	Study design: parallel RCT Time frame: not reported, but before 2002 Follow‐up period: 2 years Primary endpoint: acute rejection and kidney function 2 years after steroid withdrawal
Participants	Country: Spain Setting: single centre Cadaver kidney transplant; stable kidney function 3 months after transplantation number (randomised): withdrawal group (46); maintenance group (46) Mean age (± SD): not reported Sex (% female): not reported Exclusion criteria: PRA > 50%; previous acute rejection
Interventions	Treatment group Steroid withdrawal after 3 months Control group Steroid maintenance Baseline Immunosuppression TAC: day 0 to 15: 10 to 15 ng/mL; from day 16: 5 to 10 ng/mL MMF: 1 g/d Steroids IV methylprednisone day 0: 500 mg; day 1: 125 mg Oral prednisone: day 2 to month 2: 20 to 25 mg/d; month 2 to month 3: tapered to 5 mg/d
Outcomes	Mortality Graft loss Acute rejection NODAT SCr (mg/dL) CrCl (mL/min)
Notes	Did not report number screened for eligibility or analysed 28/120 were not randomised
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	Number of events and number of patients analysed not reported; 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