Skip to main content
. 2015 Dec 3;2015(12):CD007746. doi: 10.1002/14651858.CD007746.pub2

Busque 2001.

Methods
  • Study type: parallel RCT

  • Study time frame/year of transplantation: not reported

  • Duration of follow‐up: 6 months

Participants
  • Country: Canada

  • Setting: multicentre (6)

  • Adult recipients receiving their first cadaveric kidney transplant

    • Deceased donor: 100%

    • previous transplantation: 0%

    • PRA level: not reported

    • HLA mismatch (median): 3

    • Cold ischaemia time (mean): 15 h

    • Delayed graft function: 22%

  • Number: treatment group (23); control group (23)

  • Mean age ± SD (years): not reported

  • Sex (M/F): not reported

  • Exclusion criteria: not reported

Interventions Treatment group
  • MMF

  • 2 g/d, orally


Control group
  • AZA

  • 1.5 to 2 mg/kg body weight/d, orally


Concomitant immunosuppression
  • Induction antibody: agent unclear, if delayed graft function

  • Tac target C0 (month 3): 5 to 15 ng/mL

  • Corticosteroids

Outcomes
  • Death

  • Graft loss

  • Primary non‐function

  • Acute rejection

  • NODAT

  • Kidney function measures (SCr)

Notes
  • Additional intervention arm (CsA/MMF)

  • Publication: Transplantation Proceedings

  • Language: English

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information about the sequence generation process to permit judgment
Allocation concealment (selection bias) Unclear risk Randomisation stated, but no information on allocation method used is available
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No blinding
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgment
Incomplete outcome data (attrition bias) 
 All outcomes High risk ITT analysis unclear; number randomised or number of patients at the end of the study was not reported
Selective reporting (reporting bias) Low risk The published report included most expected outcomes regarding efficacy and safety
Other bias High risk The study was supported by Fujisawa Canada Inc.