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. 2019 Dec 16;2019(12):CD004290. doi: 10.1002/14651858.CD004290.pub3

Pascual 2010.

Methods
  • Design: open‐label RCT

  • Duration: not reported

  • Mean follow‐up: 6 months (3 withdrawn group 1; 5 in group 2)

Participants
  • Setting: multicentre, (5 centres)

  • Country: Spain

  • Patients suffering from ESKD who were candidates for primary kidney transplant or re‐transplant (except if the original graft was lost due to immunologic causes within the previous 12 months) from an ABO‐compatible donor

  • Number (group 1/group 2): 35 (15/20)

  • Mean age ± SD (years): group 1 (44 ± 11.2); group 2 (46.2 ± 10.2)

  • Sex (M/F): group 1 (10/5); group 2 (14/6)

  • Exclusions: DGF; graft from a heart‐arrest donor or from a donor’s kidney with cold ischaemia time > 30 hours; thrombocytopenia; leukopenia; significant liver disease or liver cirrhosis

Interventions Treatment group 1
  • Low‐dose EVL: 0.75 mg/twice/d unchanged to day 42; then levels of 3 to 8 ng/mL

  • sTAC: 0.075 mg/kg twice/d for levels 10 to 25 ng/mL to 14 days; 5 to 10 after 14 days


Treatment group 2
  • High‐dose EVL: 1.5 mg twice/d unchanged to day 42; then levels of 3 to 8 ng/mL

  • sTAC: 0.075 mg/kg twice/d for levels 10 to 25 ng/mL to 14 days; 5 to 10 after 14 days


Co‐interventions
  • MP: 500 mg day 0, 125 mg day 1

  • Prednisone 20 mg day 2, tapered to a maintenance dose of 5 mg from day 42 to study end

Outcomes
  • PK1 profiles of EVR and TAC

  • Acute rejection

  • Graft loss

Notes
  • Comparison: EVL low dose versus EVL high dose

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Said to be randomised; insufficient information to permit judgement
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Primary outcome lab based and unlikely to influence blinding
Incomplete outcome data (attrition bias) 
 All outcomes High risk 8/35 withdrawn (22%)
Selective reporting (reporting bias) Low risk All pre‐specified outcomes mentioned
Other bias Unclear risk Insufficient information to permit judgement