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

Martinez‐Mier 2006.

Methods
  • Design: open‐label RCT

  • Duration: May 2004 to January 2005

  • Follow up: 12 months

Participants
  • Setting: single centre

  • Country: Mexico

  • Kidney transplant recipients: all LD

  • Number (group 1/group 2): 41 (20/21)

  • Mean age ± SD (years): group 1 (29.6 ± 7.6); group 2 (31.2 ± 9.21)

  • Sex (M/F): group 1 (12/8); group 2 (12/9)

  • Exclusions: evidence of systemic infection; HLA identical donor; prior treatment for cancer; pregnancy; weight > 105 kg; hypersensitivity to macrolide antibiotics; total cholesterol > 300 mg/dL; triglycerides > 400 mg/dL; WBC < 3000/mm3, or platelets < 75,000/mm3

Interventions Treatment group 1
  • SRL: 10 mg single dose then 3 mg/m2 for levels 10 to 15 ng/mL for 3 months and then 5 to 10 ng/mL


Treatment group 2
  • CSA: 4 to 8 mg/kg for levels 150 to 300 ng/mL for 6 months and then 100 to 200 ng/mL


Co‐interventions
  • MMF: dose 2g/d

  • Basiliximab: 20 mg intraoperatively and at day 4

  • MP: 1g IV intraoperatively

  • Prednisolone: initial dose 20 mg; 5 mg at 6 months

Outcomes
  • Death (all causes)

  • Graft loss censored for death

  • Graft loss or death with a functioning graft

  • Acute rejection

  • CrCl

  • SCr

  • CAN

  • Infection

  • CMV

  • Surgical adverse effects

  • Haematological adverse effects

  • Biochemical adverse effects

  • Cosmetic/lifestyle adverse effects

Notes
  • Comparison: TOR‐I versus CNI

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement
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 Outcomes laboratory based and 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 All prespecified outcomes mentioned
Other bias Unclear risk Insufficient information to permit judgement