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

Salvadori 2007.

Methods
  • Study design: parallel RCT

  • Study duration: recruitment not reported

  • Duration of follow‐up: 12 months

Participants
  • Setting: single centre

  • Country: Italy

  • Patients aged > 55 years

  • Number: treatment group (49); control group (58)

  • Mean age ± SD (years): not reported

  • Sex (M/F): not reported

  • Exclusion criteria: not reported

Interventions Treatment group
  • Reduced dose CsA C2 levels: 900 ng/mL (months 1 and 2), 800 ng/mL (months 3 to 6)


Control group
  • Standard dose CsA C2 levels: 1500 ng/mL (month 1), tapered to 1000 ng/mL (by month 6), 800 ng/mL thereafter


Both groups
  • Basiliximab induction

  • Steroids: stopped day 8

  • EC‐MPS: 2160 mg/d for 5 days, then 1440 mg/d thereafter

Outcomes
  • Mean CrCl

  • Graft survival

  • Patient survival

  • Infection

  • BPAR

Notes
  • Abstract‐only publication

  • Funding source: not reported

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 Low risk All patient data reported
Selective reporting (reporting bias) High risk Prespecified outcomes reported; no full text publication by 2017
Other bias Unclear risk Insufficient information to permit judgement