Laftavi 2005.

Methods	Study design: parallel RCT Time frame: 2002 to 2004 Follow‐up period: 1 year Primary endpoint: not reported
Participants	Country: USA Setting: single centre First cadaveric or living kidney transplant Number (randomised): withdrawal group (32); maintenance group (28) Mean age (± SD): withdrawal group (50 ± 13); maintenance group (51 ± 12) Sex (female): withdrawal group (35%); maintenance group (36%) Donor source (living donor): withdrawal group (16%); maintenance group (21%) Exclusion criteria: PRA > 30%
Interventions	Treatment group Steroid withdrawal day 7 after transplantation Control group Steroid maintenance Baseline immunosuppression Rabbit ALG: 1mg/kg per day for 3 to 5 doses TAC: day 0: 0.5 to 1 mg twice daily adjusted to whole blood level: by day 7 to 10: 10 ng/mL; month 1 to 6: 10 to 15 ng/mL; thereafter: 8 to 10 ng/mL MMF: starting on day 0: 2 g/d divided in 2 to 4 doses. Steroids IV methylprednisone: day 0: 250 mg; day 1: 125mg Withdrawal group: prednisone: day 2: 30 mg/d; rapidly titrated down to a dose of 5 mg/d and withdrawn on day 7 Maintenance group: prednisone: day 2: 30 mg/d, rapidly titrated down to a dose of 5 mg/d by end of month 1 and thereafter maintained at 5 mg/d
Outcomes	Acute rejection Biopsy‐proven acute rejection CrCl (mL/min)
Notes	Did not report number screened for eligibility or number analysed Number of patients discontinued study Clinical adverse events, biopsy findings or subsequent pancreas transplantation: withdrawal group (10); maintenance group (6)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	'Patients were randomised by a blinded nurse coordinator according to random numbers.'
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	'A single pathologist who was blinded to the treatment arms, evaluated biopsy specimens for severity of rejection and fibrosis.'
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Unclear whether ITT analysis performed. In treatment group 16 of 32 patients and in control group 14 of 28 patients completed 1 year follow‐up
Selective reporting (reporting bias)	High risk	Mortality and graft loss are not reported
Other bias	Unclear risk	Funding source not reported Unclear whether groups were similar at baseline, because 'steroid withdrawal patients were at greater risk for rejection, having a higher average number of HLA mismatches and a greater number of African American patients'