| Methods |
Study design: parallel RCT; stratified by 1st and 2nd graft Study duration: April 1995 to February 1996 Study follow‐up: 6 months |
| Participants |
Country: Belgium Setting: single centre Inclusion criteria: DD kidney transplant recipients; ≥ 18 years Number: treatment group (20); control group (20) Mean age ± SD (years): treatment group (39.90 ± 11.38); control group (37.40 ± 11.70) Sex (M/F): treatment group (10/10); control group (10/10) 1st/2nd transplant: treatment group (16/4); control group (16/4) Exclusion criteria: not reported |
| Interventions |
Treatment group
Humanised anti‐CD2 rat MAb: BTI‐322 5 mg/d IV for 10 days. 1st dose given in operating theatre prior to vascular anastomosis MP: 250 mg at unclamping and repeat 6 h later CSA, AZA, PRED as per control
Control group
CSA: 3 to 8 mg/kg/d, adjust for trough 200 to 400 ng/mL AZA:' 1 mg/kg/d PRED: 0.5 mg/kg/d tapered to 0.1 mg/kg/d by 9 months
|
| Outcomes |
|
| Notes |
|
| 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 |
Low risk |
Unlikely to influence outcomes |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All patient outcome data reported |
| Selective reporting (reporting bias) |
Low risk |
All expected outcomes reported |
| Other bias |
High risk |
Supported by the manufacturers of BTI‐322 |
