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. 2015 Dec 3;2015(12):CD007746. doi: 10.1002/14651858.CD007746.pub2

Ji 2001.

Methods
  • Study type: quasi‐RCT

  • Study time frame/year of transplantation: 1996 to 1998

  • Duration of follow‐up: 6 months

Participants
  • Country: China

  • Setting: single centre

  • Primary deceased donor kidney transplantation; PRA negative; negative cross‐match

    • Deceased donor: 100%

    • Previous transplantation: not reported

    • PRA level: max. 6%

    • HLA mismatch (mean): 3

    • Cold ischaemia time: not reported

    • Delayed graft function: not reported

  • Number: treatment group (56); control group (50)

  • Mean age: 39

  • Sex (M/F): not reported

  • Exclusion criteria: HLA (A, B, DR) > 3 mismatches; contraindication against CsA, steroids, AZA, MMF; contraindication against oral medication

Interventions Treatment group
  • MMF

  • 1 g/d, orally


Control group
  • AZA

  • 50 mg/d, orally


Concomitant immunosuppression
  • Induction antibody: ATG/ALG, all patients

  • CsA (formulation not reported), target C0 (month 3): 500 ng/mL

  • Corticosteroids

Outcomes
  • Death

  • Graft loss

  • Primary non‐function

  • Acute rejection

  • Infections

  • Adverse events (diarrhoea, leucopenia, elevated liver enzymes)

Notes
  • Publication: full journal article

  • Language: Chinese

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quasi‐RCT, patients allocated in alternating sequence
Allocation concealment (selection bias) High risk Patients were consecutively enrolled and were allocated to the treatment arms in alternating sequence
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 Unclear risk ITT analysis unclear; all patients followed‐up
Selective reporting (reporting bias) Low risk The published report included most expected outcomes regarding efficacy and safety
Other bias Low risk The study was funded by a university grant