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

Stallone 2003.

Methods
  • Study design: parallel RCT

  • Study duration: recruitment not reported

  • Duration of follow‐up: 12 months

Participants
  • Setting: single centre

  • Country: Italy

  • Consecutive kidney transplant recipients from cadaveric donors

  • Number: treatment group (20); control group (20)

  • Mean age ± SD (years): treatment group (40 ± 10); control group (47 ± 5)

  • Sex (M/F): not reported

  • Exclusion criteria: not reported

Interventions Treatment group
  • CsA withdrawal

  • SRL trough levels: 10 to 15 ng/mL

  • PRED


Control group
  • CsA trough levels: 150 to 250 ng/mL

  • SRL: 2 mg/d

  • PRED


Both groups (to 3 months)
  • PRED: 200 mg/d then tapered to 25 mg (day 8) and to 5 mg (month 6)

  • CsA trough levels: 150 to 250 ng/mL

  • SRL: 2 mg/d

Outcomes
  • Graft biopsy at 12 months for chronic changes

  • Incidence of DGF

  • AR

  • Graft function

  • CrCl

Notes
  • 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 No blinding of outcome assessment
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All patients accounted for
Selective reporting (reporting bias) Low risk All prespecified outcomes reported
Other bias Low risk Insufficient information to permit judgement