Stevens 2008.

Methods	Study design: parallel RCT; stratified into 6 groups: white versus non‐white, DD versus LD; listed for pancreas after kidney versus not listed Study duration: April 2004 to December 2007 Study follow‐up: 6 months
Participants	Country: USA Setting: single centre Inclusion criteria: 18 to 64 years; LD or DD kidney transplant recipients; 1st or repeat transplant Number (analysed/randomised): treatment group 1 (70/79); treatment group 2 (72/81) Mean age ± SD (years): treatment group 1 (45.5 ± 12.4); treatment group 2 (49.3 ± 10.5) Sex (M/F): treatment group 1 (46/24); treatment group 2 (45/27) White‐Asian/other: treatment group 1 (62/8); treatment group 2 (61/11) LD/DD: treatment group 1 (30/40); treatment group 2 (31/41) Exclusion criteria: > 65 years; PRA > 75%; HLA‐identical recipients; required chronic steroids
Interventions	Treatment group 1 Single high dose rATG: 6 mg Infused over 24 h in 1 L of normal saline, started in operating theatre, prior to re‐perfusion Treatment group 2  Split dose rATG: 4 x 1.5 mg doses over 7 days (day 0, 2, 4, 6) 1st dose 1.5 mg/kg over 24 h, started before reperfusion Subsequent doses in 250 mL over 6 to 12 h every 2nd day Pre‐meds, immunosuppression, prophylaxis (both groups) Pre‐med: MP, paracetamol, antihistamine MP: 3 mg/kg every 6 h for 24 h Immunosuppression TAC: 1 to 3 mg twice daily when Cr < 3g/dL (trough target 4 to 6 ng/mL, 2 to 4 ng/mL after 3/12) Sirolimus: 5 mg 4 times/d when SCr < 3 mg/dL, (trough 8 to 10 ng/mL to 3 months, 4 to 8 ng/mL after 3 months) MMF: used if BMI > 32, 500 to 1000 mg twice/d Prophylaxis Valaciclovir for 3 months Clotrimazole for 3 months Co‐trimoxazole (or dapsone or aerosolized pentamidine if allergy) for PCP for 3 months
Outcomes	Kidney function (eGFR) CAN by protocol biopsy at 6 months Biopsy‐proven acute rejection Patient survival Graft survival Safety profile NODAT
Notes	Switch in maintenance immunosuppression at 6 months. Either CNI withdrawal and switch to MMF or continued on TAC. 50% of each group. These results not reported, therefore outcomes only to 6/12 Funding source: "supported by the Ann Goldstein‐Cheryl Cooper New Frontiers in Transplant Medicine Fund, a Research Support Fund grant from the Nebraska Medical Center and the University of Nebraska Medical Center and an unrestricted research grant from Genzyme, Inc"
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	‘Randomly generated treatment group assignments’ after stratification into 6 different groups
Allocation concealment (selection bias)	Low risk	‘Sequentially numbered sealed envelopes’.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Unlikely to influence outcomes
Blinding of outcome assessment (detection bias) All outcomes	Low risk	All patient outcome data reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups
Selective reporting (reporting bias)	High risk	Primary outcomes not well reported (graphs only, no figures reported for kidney function)
Other bias	Unclear risk	Partly funded by Genzyme with unrestricted grant. (but ATG in both arms)