Boots 2002.

Methods	Study design: parallel RCT Time frame: 1997 to 2000, excluding October 1998 to October 1999 (a different multicentre study during that period) Follow‐up period: 2.7 years (range 0.9 to 3.4) years Primary endpoints: patient survival, graft survival, incidence of first acute rejection in first 6 months after transplantation
Participants	Country: The Netherlands Setting: multicentre (number of centres not reported) First and second cadaveric or living kidney transplant; Previous graft loss not because of immunological causes; PRA < 50%; 18 to 65 years Number (randomised/analysed): avoidance group (28/28); withdrawal group (34/34) Mean age ± SD (years): avoidance group (54 ±14); withdrawal group (48 ± 13) Sex (female): avoidance group (61%); withdrawal group (35%) Donor source (living donors): avoidance group (14%); withdrawal group (12%) Exclusion criteria: HLA identical living donor; mismatch on HLA‐B or HLA‐DR locus
Interventions	Avoidance group Steroid withdrawal 7 days after transplantation or after TAC levels > 15 ng/mL Withdrawal group Steroid withdrawal 3 to 5 months after transplantation Baseline immunosuppression TAC: started within 12 hours before transplantation with 0.1 to 0.15 mg/kg twice daily adjusted to trough levels: week 1 to 2: 15 to 20 ng/mL; week 3 to 4: 10 to 15 ng/mL; thereafter: reduced to 5 to 7 ng/mL 6 months after transplantation Steroids IV methylprednisone: day 0: 125 mg Avoidance group: oral prednisone: day 1 to 8: 10 mg, then stopped Withdrawal group: oral prednisone: month 1: 10 mg; month 2: 7.5 mg; month 3: 5 mg; then withdrawn within 1 to 3 months
Outcomes	Mortality Graft loss Acute rejection Biopsy‐proven acute rejection SCr (mg/dL) CrCl (mL/min) NODAT Infection
Notes	Number screened for eligibility: 76
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomisation was performed by opening a closed opaque numbered envelope
Allocation concealment (selection bias)	Low risk	Stated 'closed opaque 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	All patients followed up or accounted for; ITT analysis performed ('Analyses were made on an ITT basis.'
Selective reporting (reporting bias)	Low risk	Primary outcomes for this review have been reported
Other bias	Unclear risk	Funding source not reported