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. 2017 Jul 21;2017(7):CD006750. doi: 10.1002/14651858.CD006750.pub2

Kreis 2003.

Methods
  • Study design: parallel RCT

  • Study duration: not reported

  • Duration of follow‐up: 2 years

Participants
  • Setting: multicentre

  • Country: France

  • 1st or 2nd kidney transplant recipients randomised week 8 post‐transplant

  • Number: treatment group (78); control group (80)

  • Mean age ± SD (years): not reported

  • Sex (M/F): not reported

  • Exclusion criteria: not reported

Interventions Treatment group
  • Early CsA reduction trough levels: 100 to 150 ng/mL (week 9 to 12), 75 to 100 ng/mL (week 12 to month 12), 75 ng/mL (months 12 to 24)


Control group
  • CsA reduction after 1 year: 150 to 200 ng/mL (week 9 to month 12) and 100 to 150 ng/mL (months 12 to 24)


Both groups
  • Daclizumab induction

  • MMF: 2 g/d

  • Steroids

Outcomes
  • SCr

  • BPAR

  • Graft survival

  • Patient survival

Notes
  • Funding source: not reported

  • Abstract‐only publications

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Study was described as randomised, method of randomisation was not reported
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement
Other bias Unclear risk Insufficient information to permit judgement