Kumar 2005.

Methods	Study design: parallel RCT Time frame: 2000 to 2002 Follow‐up period: 1 year Primary endpoint: not reported
Participants	Country: USA Setting single centre Age > 20 years; first cadaveric or living kidney transplant Number (randomised/analysed): withdrawal group (45/45); maintenance group (32/32) Mean age ± SD (years): withdrawal group (50 ± 13); maintenance group (54 ± 13) Sex (female): withdrawal group (28%); maintenance group (28%) Donor source (living donors): withdrawal group (18%); maintenance group (9%) Exclusion criteria: PRA > 10%; HIV seropositivity; HBsAG seropositivity
Interventions	Treatment group Steroid withdrawal 7 days after transplantation Control group Steroid maintenance Baseline immunosuppression Basiliximab: days 0, 4: 20 mg Withdrawal group: the first 17 patients received additionally 20 mg on day 60 and 64 CsA: starting day 1 with 2 to 5 mg/kg twice daily, adjusted to trough blood levels: day 1 to 100: 250 to 300 ng/mL; day 101 to 365: 200 to 250ng/mL; thereafter: 150 to 200 ng/mL MMF: 2 to 3 g/d MMF intolerance: SRL: started with 5 mg/d adjusted to blood level 6 to 10 ng/mL Steroids: IV methylprednisone: day 0: 250 mg; day 1: 125 mg Oral prednisone Withdrawal group: first 17 patients: day 2: 30 mg, tapered by 5 mg/d until withdrawal on day 7; remaining 28 patients: no further steroids Maintenance group: day 2: 30 mg; tapered to 5 mg/d at month 1
Outcomes	Mortality Graft loss Acute rejection NODAT SCr (mg/dL)
Notes	Did not report number screened for eligibility Study was closed after 77 patients were randomised, because patients refused to be randomised in the maintenance group. Nevertheless 300 patients were enrolled through patient's choice. This systematic review only includes data on the randomised first 77 patients 7 patients in withdrawal group and 3 patients in maintenance group received SRL because of MMF intolerance Contact with study authors for additional information: authors contacted 5 July 2013; no response received
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	'Randomization was completed using the first generator plan from randomization.com.'
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	Low risk	ITT analysis performed; all patients followed up or accounted for
Selective reporting (reporting bias)	Low risk	Primary outcomes for this review reported
Other bias	High risk	First 17 patients (38%) in withdrawal group received steroids until day 7 and two additional doses of basiliximab, the remaining 28 patients (62%) received steroids until day 2 and no additional basiliximab 'The study was funded internally by clinical revenue. The manuscript was support by an unrestricted educational grant from Novartis Pharm. Corp.'