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

Pisani 2001.

Methods

  • Study design: parallel RCT

  • Time frame: not reported

  • Follow‐up period: not reported

  • Primary endpoint: incidence of acute rejection
Participants

  • Country: Italy

  • Setting: single centre

  • First or second kidney transplant

  • Number (analysed): withdrawal group (15); maintenance group (15)

  • Mean age: withdrawal group (41 years); maintenance group (45 years)

  • Sex (female): withdrawal group (33%); maintenance group (30%)

  • Donor source (% living donors): not reported

  • Exclusion criteria: not reported
Interventions Treatment group

  • Steroid withdrawal 6 months after transplantation


Control group

  • Steroid maintenance


Baseline immunosuppression

  • Basiliximab: day 0 and 4: 20 mg

  • CsA: started with 8 mg/kg/d adjusted to blood levels in month 1 to 2: 350 to 400 ng/mL; month 3: 250 to 300 ng/mL

  • MMF: 1500 mg/d

  • Steroids

    • IV methylprednisone day 0: 500 mg

    • Oral prednisone: month 1: 20 mg/d; tapered to 5 mg/day at month 3
Outcomes

  • Mortality

  • Graft loss

  • Acute rejection

  • SCr (µmol/L)

  • NODAT

  • Infection

  • CMV infection
Notes

  • Did not report number screened for eligibility; randomised (46); analysed (30)

  • Steroids withdrawn in 8/15 patients in withdrawal group at time of preliminary report

  • This study had a third arm with 'standard immunosuppression' CsA + MMF + steroids (17 patients)

  • Contact with study authors for additional information: authors contacted 9 July 2013; no response received
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Stated 'randomised' but no further information provided.
Allocation concealment (selection bias) Unclear risk Not reported
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Not reported
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not reported
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Outcomes are objective hard endpoints
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Unclear whether ITT analysis was performed; number of patients per group and in total vary between reports
Selective reporting (reporting bias) Low risk Primary outcomes for this review reported
Other bias Unclear risk Funding source not reported
Abstract‐only data
Lack of important information regarding design and conduct of study