Cole 1994.

Methods	Study design: parallel RCT, stratified for the DM and for each centre Study duration: not reported Study follow‐up: 1 year
Participants	Country: USA Setting: multicentre (3) Inclusion criteria: adult 1st DD kidney transplant recipients Number: treatment group 1 (83); treatment group 2 (83) Mean age, range (years): treatment group 1 (48.43, 22 to 72); treatment group 2 (47.31, 22 to 70) Males: treatment group 1 (66%); treatment group 2 (60%) Exclusion criteria: refused consent; positive skin test to rATG
Interventions	Treatment group 1 RATG: 0.15 mL/kg/d as continuous IV infusion within 12 h of transplant; adjusted to keep lymphocyte count < 200/mL3; given for 10 to 14 days CSA initiated at 2 mg/kg twice daily once kidney function was established (SCr < 250 µmol/L) but at least 7 days after surgery; target trough of 100 to 300 ng/mL Treatment group 2 OKT3: 5 mg given during operation prior to anastomosis, then 5 mg/d IV infusion MP: 1 mg/kg IV plus 50 mg oral or IV Benadryl and 650 mg acetaminophen every 6 h were given 1 h before OKT3 administration for the 1st 2 or 3 doses CD3 levels not routinely monitored Immunosuppression (both groups) MP: 1 mg/kg IV within 1 h of transplant; 0.25 mg/kg every 6 h post‐op for 48 h; converted to PRED (0.5 mg/kg/d) then tapered to 0.2 mg/kg/d by day 11, 0.15 mg/kg/d by week 6 and continued for 1 year AZA: 1 mg/kg IV within 1 h of transplant and then continued at 1 mg/kg/d for 1 year unless WCC > 3000/mL3
Outcomes	Death Graft loss Acute rejection Infection (not able to be included in review as reported as total number of infections rather than total number of patients with infection)
Notes	Kidney function: SCr at 1, 3, 6 and 12 months 'similar' both groups (numbers not given) Funding source: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information to permit judgement
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Unlikely to influence outcomes
Blinding of outcome assessment (detection bias) All outcomes	High risk	Clinically diagnosed acute rejection (no biopsy‐proven acute rejection)
Incomplete outcome data (attrition bias) All outcomes	Low risk	All patient outcome data reported
Selective reporting (reporting bias)	High risk	Expected outcomes reported, however infection data cannot be included in our meta‐analysis
Other bias	Unclear risk	Funding source not reported