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. 2010 Jan 20;2010(1):CD003897. doi: 10.1002/14651858.CD003897.pub3

Lacha 2001.

Methods
  • open label RCT

Participants
  • Setting: Single centre

  • Country: Czech Republic

  • Immunologically high risk kidney transplant recipients (PRA > 50% or previous graft loss due to rejection during first year)

  • Age: NS

  • Number (group 1/group 2): 72 (38/34)

  • Exclusions: NS

Interventions Treatment group 1
  • Daclizumab: 2 mg/kg then 1 mg/kg on day 7, 14 and 28


Treatment group 2
  • Muromonab‐CD3: 5 mg day 1 then 2.5 mg days 2‐7


Baseline immunosuppression
  • CSA: 8 mg/kg then tapered according to trough levels (NS)

  • MMF: 2 g/d

  • Steroids: NS

Outcomes
  • Graft loss

  • Acute rejection

  • CMV

  • Adverse reaction

Notes
  • 6 month follow‐up

  • New data available form 2004 abstract (more participants)

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Stated "randomised" no further information provided
Allocation concealment (selection bias) Unclear risk Not stated
Blinding (performance bias and detection bias) 
 Objective outcomes Unclear risk Open‐label, blinding of outcome assessors not stated
Blinding (performance bias and detection bias) 
 Subjective outcomes Unclear risk Open‐label, blinding of outcome assessors not stated
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Unclear reporting of numbers in each group
Selective reporting (reporting bias) Unclear risk Death not reported, discussion states "...graft outcomes, survival rates and graft function is similar in both groups"
Other bias Unclear risk Source of funding not stated