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. 2017 Mar 31;2017(3):CD011639. doi: 10.1002/14651858.CD011639.pub2

Jonas 2005.

Methods Randomised clinical trial
Participants Country: Germany
Number randomised: 121
Postrandomisation dropouts: 0 (0%)
Revised sample size: 121
Average age: 48 years
Females: 71 (58.7%)
Primary transplantation: 121 (100%)
Retransplantation: 0 (0%)
HCV: 35 (28.9%)
HBV: 30 (24.8%)
Alcoholic cirrhosis: 20 (16.5%)
Other causes: 37 (30.6%)
Average follow‐up period in months (for all groups): 144
Additional treatment such as antiviral drugs: none stated
Important inclusion and exclusion criteria
Primary transplantation only: yes
Retransplantation only: no
HCV only: no
HBV only: no
Alcoholic cirrhosis only: no
Other causes: yes
Important exclusion criteria:

  • Vasculitis or arteritis

  • Primary liver cancer with metastasis

  • Active neoplastic disease

  • HIV positive

  • Multiple organ transplantation

  • Treatment with an investigational agent with no safety data in the previous 28 days

  • Total lymphoid irradiation in the previous 6 months

  • Pregnant women or women not using adequate contraception
Interventions Participants were randomly assigned to 2 groups.
 Group 1: cyclosporine A plus azathioprine (n = 60).
 Further details: cyclosporine A: attain 600 to 900 ng/mL; azathioprine: 1 to 2 mg/kg/day.
 Group 2: tacrolimus (n = 61).
 Further details: tacrolimus: 0.10 to 0.15 mg/kg/day.
Outcomes The outcomes reported were:

  • mortality,

  • graft loss,

  • retransplantation,

  • graft rejection.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: this information was not available.
Allocation concealment (selection bias) Unclear risk Comment: this information was not available.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "open‐label"
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "open‐label"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: there were no postrandomisation dropouts.
Selective reporting (reporting bias) High risk Comment: no published protocol was available; either mortality/graft loss or adverse events, or both were not reported.
For‐profit bias High risk Quote: "this study was sponsored by Fujisawa Pharmaceutical Co Ltd, Osaka, Japan"
Other bias Low risk Comment: no other bias noted.