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

Weimer 2002.

Methods
  • Study type: parallel RCT

  • Study time frame/year of transplantation: 1998 to 2000

  • Duration of follow‐up: 2 years

Participants
  • Country: Germany

  • Setting: single centre

  • Patients receiving a kidney allograft (deceased or living donor)

    • Deceased donor: 75%

    • Previous transplantation: 14.3%

    • PRA level: max 8%

    • HLA mismatch (mean): 2.6

    • Cold ischaemia time (mean): 13 h

    • Delayed graft function: 16 %

  • Number: treatment group (31); control group (25)

  • Mean age: 47 years

  • Sex: 39% male

  • Exclusion criteria: not reported

Interventions Treatment group
  • MMF

  • Dose unclear


Control group
  • AZA

  • Dose unclear


Concomitant immunosuppression
  • Induction antibody: ATG if previous transplantation, or PRA > 5 %, or delayed graft function

  • CsA‐ME, target C0 (month 3): not reported

  • Corticosteroids

Outcomes
  • Death

  • Graft loss

  • Primary non‐function

  • Acute rejection

  • CAN

  • Infections

  • Kidney function measures (SCr, CrCl)

Notes
  • Additional intervention arm (Tac/AZA)

  • Publication: full journal article

  • 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 Low risk ITT analysis reported; all patients followed up or accounted for
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 in part by the Fujisawa, Roche, Novartis, Biotest and Fresenius companies