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. 2019 Dec 16;2019(12):CD004290. doi: 10.1002/14651858.CD004290.pub3

Pescovitz 2007.

Methods
  • Design: open‐label RCT

  • Duration: not reported

  • Follow up: 6 months

Participants
  • Setting: multicentre (6 centres)

  • Country: USA

  • Kidney transplant recipients aged 18 to 75 years able to take oral medications

  • Number (group 1/group 2): 45 (30/15)

  • Median age, range (years): group 1 (49.0, 21 to 70); group 2 (47.0, 28 to 64)

  • Sex (M/F): group 1 (16/14); group 2 (12/3)

  • Exclusions: HLA identical; PRA > 20%; HIV +ve; HepB surface antigen +ve; WBC < 2.5 x 109; platelets <100 x 109; Hb < 6 g/dL; hyperlipidaemia in previous year; African‐Americans GI disorders likely to impair absorption; previous cancers; previous treatment with daclizumab

Interventions Treatment group 1
  • SRL: 15 mg/d for days 1 to 3; then 10 mg/day to 10 to 25 ng/mL at 2 months; maintenance 8 to 15 ng/mL


Treatment group 2
  • CSA: administered according to centre practice


Co‐interventions
  • Daclizumab

  • MMF: 2 g/d

  • Prednisolone

Outcomes
  • Death (all causes)

  • Graft loss censored for death

  • Graft loss or death with a functioning graft

  • Acute rejection

  • CrCl

  • SCr

  • Malignancy

  • Biochemical adverse effects

Notes
  • Comparison: TOR‐I versus CNI

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Enrolled 2:1 before transplant. No other information provided
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 Low risk Primary outcomes BPAR, death, graft loss unlikely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All patients accounted for
Selective reporting (reporting bias) Low risk Expected outcomes reported
Other bias High risk Sponsored by Roche