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. 2017 Jan 11;2017(1):CD004759. doi: 10.1002/14651858.CD004759.pub2

Smeekens 2013.

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
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
Interventions Treatment group

  • Rituximab: single dose 375 mg/m2 IV (500 mL bag) at the time of transplantation


Control group

  • Placebo: identical 500 mL bag


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‐
Outcomes

  • Biopsy‐proven acute rejection

  • Patient survival

  • Graft survival

  • Graft function (CrCl)

  • CAN

  • Infection

  • Malignancy

  • Cost
Notes

  • Funding source: "Funding for the clinical trial was provided by Hoffmann–La Roche and Astellas Pharma. Rituximab (MabThera, Hoffman‐La Roche) was donated."
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.'