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. 2016 Aug 22;2016(8):CD005632. doi: 10.1002/14651858.CD005632.pub3

De Vecchi 1986.

Methods
  • Study design: parallel RCT

  • Time frame: not reported but before 1986

  • Follow‐up period: 2 years

  • Primary endpoint: not reported

Participants
  • Country: Italy

  • Setting: single centre

  • Cadaveric kidney transplantation, no further inclusion criteria provided

  • Number (randomised/analysed): withdrawal group (25/25); maintenance group 26/26)

  • Mean age ± SD (years): withdrawal group (36 ± 12); maintenance group (36 ± 10)

  • Sex (female): withdrawal group (48%); maintenance group (35%)

  • Exclusion criteria: not reported

Interventions Treatment group
  • Steroid withdrawal day 1 after transplantation


Control group
  • Steroid maintenance


Baseline immunosuppression
  • CsA: day 0 to 3: 5 mg/kg/d IV; from day 4: 15 mg/kg/d PO; tapered by 2 mg/kg every 16 days until maintenance dose of 5 mg/kg/d at month 4, given as single morning dose

  • Steroids

    • IV methylprednisone: 500 mg during transplantation

    • Withdrawal group: no further steroids.

    • Maintenance group: methylprednisone: day 1: 160 mg IV; day 2: 120 mg IV; day 3: 16 mg; reduced by 4 mg every 2 months until maintenance dose of 8 mg/d by the end of month 6

Outcomes
  • Mortality

  • Graft loss

  • Acute rejection

  • SCr (mg/dL)

Notes
  • Did not report number screened for eligibility

  • Number of patients discontinued treatment

    • 18 patients in the withdrawal group had steroids added

    • 6 patients in withdrawal group switched to AZA or triple immunosuppression and were excluded

    • 5 patients in maintenance group switched to AZA or triple immunosuppression and were excluded

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Stated 'randomly assigned' but no further information provided
Allocation concealment (selection bias) Low risk Stated 'assigned by sealed envelopes'
Blinding (performance bias and detection bias) 
 All outcomes High risk Open‐label
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Outcomes are objective hard endpoints
Incomplete outcome data (attrition bias) 
 All outcomes High risk ITT analysis not performed; 6 patients in treatment group and 5 patients in control group excluded because of switch to different immunosuppression
Selective reporting (reporting bias) Low risk Primary outcomes for this review reported
Other bias Low risk Funded by grant of the Consiglio Nazionale delle Richerche