| Methods |
Study design: parallel RCT Study duration: not reported Study follow‐up: 3 months |
| Participants |
Country: France Setting: single centre Inclusion criteria: 1st DD kidney transplant recipients Number: treatment group (6); control group (7) Mean age ± SD (years): treatment group (34.3 ± 9.2); control group (35.7 ± 11.2) Sex (M/F): treatment group (3/3); control group (4/3) Exclusion criteria: not reported |
| Interventions |
Treatment group
OKT3: 5 mg/d, IV for 14 days starting 1 day pre‐transplant (pre‐treatment skin test prior) then stopped AZA: 3 mg/kg/d from day 14
Control group
AZA: 3 mg/kg/d, given from 1 day pre‐op PRED: 5 mg/kg/d for 5 days, then tapered to 0.25 mg/kg/d over 11 weeks
|
| Outcomes |
Death Graft loss Acute Rejection Bacterial infection CMV disease Tolerance of OKT3 |
| Notes |
If episode of acute rejection, OKT3 was stopped and patient was switched to PRED and AZA Very early study possibly 1st using OKT3 as prophylaxis Pre CNI maintenance All patients in OKT3 group had side effects with fever, chills, anxiety and diarrhoea for 1st infusion and then not after (? vs none in control group although not actually reported) All developed antibodies to OKT3 Not effective as single agent (worse outcomes compared to controls) Funding source: not reported, however 1 author an employee of Ortho Pharmaceuticals |
| 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 |
Unclear risk |
Most cases of acute rejection were biopsy‐proven acute rejection but not all. Clinical decision for acute rejection without biopsy could be prone to bias |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All patient outcome data reported |
| Selective reporting (reporting bias) |
Low risk |
All expected outcomes reported given short term follow‐up only |
| Other bias |
High risk |
Funding source not declared; one of the authors is from Ortho Pharmaceutical Corporation (OKT3 manufacturer) |
