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

Niaudet 1990.

Methods
  • Study design: parallel RCT

  • Study duration: September 1987 to May 1988

  • Study follow‐up: not reported

Participants
  • Country: France

  • Setting: single centre

  • Inclusion criteria: children, 1st DD kidney transplant recipients

  • Number: treatment group 1 (14); treatment group 2 (14)

  • Mean age ± SD (years): not reported

  • Sex (M/F): not reported

  • Exclusion criteria: not reported

Interventions Treatment group 1
  • OKT3 (Cilag): 1 mL/10 kg up to 40 kg, 5 mL if over 40 kg, given for 21 days

    • Given via peripheral vein over 2 min, 1st dose prior to reperfusion


Treatment group 2
  • ALG (Merieux) 1mL/kg via AVF or CVC via IV infusion over 12 h; given for 21 days


Immunosuppression (both groups)
  • AZA: 0.75 to 1.5 mg/kg/d

  • PRED: 60 mg/m2/d, tapered to 30 mg/m2 by day 30

  • CSA: 150 mg/m2 from day 18, adjusted to maintain level 100 to 200 ng/mL

Outcomes
  • Patient survival

  • Graft survival

  • Acute rejection

  • Infection

  • Other side effects

Notes
  • No table 1, states similar for age, sex, previous blood transfusions, HLA, PRA, cold ischaemia time

  • There was also a 2nd part to paper about high dose versus low dose OKT3. There was limited info but low and high dose groups did not appear to be randomised. This data therefore not included

  • 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 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 Unclear risk Funding source not reported