Ruggenenti 2006.

Methods	Pilot, exploratory RCT Patients stratified based on: Group A: living‐related transplant, increased immunologic risk (PRA > 50%) or previous transplant Group B: delayed graft function (need for dialysis with 3 days of transplant) Within each group patients were randomised 1:1 Group A: randomised at time of transplant Group B: randomised at first dialysis session
Participants	Setting: Single centre Country: Italy Sensitized recipients (4); second transplant (8); cadaveric donor (28) Age: NS Sex (M/F): 11/22 Number (treatment/control): 33 (17/16) Exclusions: previous non‐kidney transplant; multiple organ transplants; HLA‐identical living donors
Interventions	Treatment group Basiliximab: 20 mg, day 0 and 4 Low‐dose ATG: 0.5 mg/kg/d, days 0‐7 Control group Standard‐dose ATG: 2 mg/kg/d, days 0‐7 Baseline immunosuppression CSA: 3‐5 mg/kg/d IV for 24‐36 h; orally 8‐10 mg/kg/d tapered to 4 mg/kg/ day over first month. Trough levels 250‐440 ng/mL days 0‐7, 200‐300 ng/mL days 8‐28 and 150‐250 ng/mL to study end MMF: 2 g/d from day 1 Steroids: 500 mg day 0 and tapered accounting to protocol to 8 mg/d from day 120
Outcomes	Mortality Acute rejection Graft loss Infection Adverse reaction
Notes	6 month follow‐up
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Randomly assigned on a 1:1 basis", no further information provided
Allocation concealment (selection bias)	Low risk	Patient allocation was centralized (at the Unit of Biostatistics) under the responsibility of an independent investigator who was not involved in study design or conduct
Blinding (performance bias and detection bias) Objective outcomes	High risk	Open‐label, blinding of outcome assessors not stated
Blinding (performance bias and detection bias) Subjective outcomes	High risk	Open‐label, blinding of outcome assessors not stated
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT, all patients accounted for
Selective reporting (reporting bias)	Low risk	Primary outcomes for this review (death, graft loss and acute rejection) were reported
Other bias	Low risk	"No pharmaceutical company involvement", study was initiated and internally funded