Methods |
Study design: parallel RCT; stratified by PRA and history of previous transplant
Study duration: December 2007 to June 2012
Study follow‐up: to 6 months
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Participants |
Country: Netherlands
Setting: single centre
Inclusion criteria: LD or DD kidney transplant recipients; 18 years
Number: treatment group (138); control group (142)
Mean age ± SD (years): treatment group (50.8 ± 13.2); control group (49.8 ±12.3)
Sex (M): treatment group (69.6%); control group (63.4%)
LD/DD: treatment group (58.7/41.3); control group (57.0/43.0)
Ethnicity (white): treatment group (94.9%); control group (96.5%)
Exclusion criteria: HLA identical living donor; haemolytic uraemic syndrome as original kidney disease; focal segmental glomerulosclerosis that had recurred in a previous graft; 3 or more previously failed grafts; a current or historic PRA > 85%; total WCC < 3.0 x 109/L; platelet count < 75 x 109/L; active infection with Hep B, Hep C or HIV; a history of tuberculosis; previous treatment with rituximab
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Interventions |
Treatment group
Control group
Pre‐med, immunosuppression and prophylaxis (both groups)
PRED: 100 mg at start of operation; 100 mg/d for 3 days; 15‐5 mg/d and tapered to 0.1 mg/kg/d
Clemastin: 2 mg at start of operation
Standard antibiotic prophylaxis at start of operation
TAC: 0.1 mg/kg twice daily, target trough 15 to 20 ng/mL for 2 weeks, then 10 to 15 ng/mL for 4 weeks, thereafter 5 to 10 ng/mL
MMF: 1000 mg twice daily for 2 weeks, then 1500 mg/d thereafter (or 2000 mg if weight > 90 kg),
Co‐trimoxazole: 480 mg daily for 3 months, then 3 times/week until 12 months
Valganciclovir: for 3 months if CMV D+/R‐
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Outcomes |
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Notes |
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Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Computer generated list of random numbers, prepared by independent investigator |
Allocation concealment (selection bias) |
Low risk |
Study numbers only available to authorised nurses who signed confidentiality statements. Medication prepared by authorised nurses |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Medication in identical bags for rituximab and placebo |
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 |
Low risk |
None apparent. 'Both companies were informed of the results and had no role in study design, data collection, analysis, interpretation or writing of the report.'
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