FRANCIA Study 2007.

Methods	Study design: parallel RCT Time frame: 2001 to 2005 Follow‐up period: 1 year Primary endpoint: acute rejection during first year after transplantation
Participants	Country: France Setting: multicentre (6 centres) First cadaveric kidney transplantation; aged 18 to 65 years Number (randomised/analysed): withdrawal group (98/103); maintenance group 103/99) Mean age, range (years): withdrawal group (48, 19 to 65); maintenance group (48, 17 to 65) Sex (female): withdrawal group (28%); maintenance group (35%) Exclusion criteria: PRA > 20%; cold ischaemia time > 36 hours; malignancy; immunosuppressive therapy before transplantation; wait listed for another transplant; leucocytes < 2000/mm3; platelets < 50000/mm3; underlying kidney disease; focal and segmental glomerular sclerosis
Interventions	Treatment group Steroid withdrawal day 1 after transplantation Control group Steroid maintenance until at least 6 months after transplantation, thereafter according to centre practice Baseline immunosuppression ATG: day 0: 9 mg/kg; day 1, 3, 5, 7: 3 mg/kg CsA: starting on day 5 with 8 mg/kg/d, divided into 2 single doses, adjusted to trough levels 150 to 200 ng/mL MMF: 1000 mg/d twice daily, adjusted to centre practice Steroids IV methylprednisone day 0: 500 mg Withdrawal group: no further steroids Maintenance group: prednisone: day 0 to 5: 1 mg/kg/d; day 6 to 10: 0.5 mg/kg/d; day 11 to 15: 0.25 mg/kg/d; day 16 to 30: 0.2 mg/kg/d; day 31 to 180: 0.1 mg/kg/d; after day 180 according to centre practice
Outcomes	Mortality Graft loss Acute rejection SCr (µmol/L)
Notes	Did not report number screened for eligibility Number of patients excluded from analysis: maintenance group (4) because of substantial deviations from the immunosuppressant therapy protocol Number of patients discontinued study: 3 patients were excluded after randomisation
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	'Eligible patients were assigned to CS or non‐CS treatment at a 1:1 ratio using block randomization with stratification according to the recipient's age and cold ischaemia time.'
Allocation concealment (selection bias)	Low risk	'Treatment codes were provided in sealed 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	ITT analysis performed; 4 patients in control group excluded from analysis for acute rejection but included for patient and graft survival analysis.
Selective reporting (reporting bias)	Low risk	Primary outcomes for this review reported.
Other bias	High risk	TAC, SRL, EVL, AZA could be introduced according to centre practice Steroid dosing after 6 months according to centre practice, unclear whether patients were withdrawn from steroids or maintained on steroids Study was sponsored by the Nantes University Hospital Statistical analysis of study data was supported by Fresenius Biotech GmbH, Germany