Skip to main content
. 2017 Mar 31;2017(3):CD011639. doi: 10.1002/14651858.CD011639.pub2

Masetti 2010.

Methods Randomised clinical trial
Participants Country: Italy
Number randomised: 78
Postrandomisation dropouts: 0 (0%)
Revised sample size: 78
Average age: 54 years
Females: 18 (23.1%)
Primary transplantation: 78 (100%)
Retransplantation: 0 (0%)
HCV: not stated
HBV: not stated
Alcoholic cirrhosis: not stated
Other causes: not stated
Average follow‐up period in months (for all groups): 22
Additional treatment such as antiviral drugs: none stated
Important inclusion and exclusion criteria
Primary transplantation only: yes
Retransplantation only: no
HCV only: not stated
HBV only: not stated
Alcoholic cirrhosis only: not stated
Other causes: not stated
Important exclusion criteria:

  • HIV positive

  • Women who were pregnant or breastfeeding

  • Recipients of multiple‐organ transplant

  • ABO‐incompatible transplants

  • Living‐related or ‐unrelated donor transplants

  • People with thrombocytopenia, leukopenia, hypercholesterolaemia, or hypertriglyceridaemia

  • Renal failure
Interventions Participants were randomly assigned to 2 groups.
 Group 1: everolimus (n = 52).
 Further details: everolimus: attain 6 to 10 ng/mL.
 Group 2: cyclosporine A (n = 26).
 Further details: cyclosporine A: attain 125 to 175 ng/mL.
Outcomes The outcomes reported were:

  • mortality,

  • adverse events,

  • 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 post‐randomisation drop‐outs.
Selective reporting (reporting bias) Low risk Comment: no published protocol available; mortality/graft loss and adverse events were reported.
For‐profit bias Unclear risk Comment: this information was not available.
Other bias Low risk Comment: no other bias noted.