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

Stiller 1983.

Methods
  • Study design: parallel RCT

  • Time frame: 1982 to 1983

  • Follow‐up period: not reported

  • Primary endpoint: not reported

Participants
  • Country: Canada

  • Setting: multicentre (9 centres)

  • First or subsequent cadaveric or living kidney transplant; > 12 years

  • Number (randomised): no steroids group (33); maintenance group (36)

  • Mean age: no steroids group (35 years); maintenance group (35 years)

  • Sex (female): no steroids group (33%); maintenance group (36%)

  • Donor source (living donor): no steroids group (18%); maintenance group (36%)

  • Exclusion criteria: acute or progressive liver disease; previous generalised or metastatic malignancy; localised malignancy within the previous year; disease requiring maintenance steroid

Interventions Treatment group
  • No steroids at any time


Control group
  • Steroid maintenance


Baseline immunosuppression
  • CsA: prior to transplantation: 15 mg/kg, thereafter 7.5 mg/kg twice daily adjusted to trough levels: day 1 to 60: 100 to 300 ng/mL; thereafter: 50 to 200 ng/mL

  • Steroids

    • Maintenance group: prednisone: 1 mg/kg alternate day reduced by 5 mg every other day to 0.3 mg/kg/d

Outcomes
  • Mortality

  • Graft loss

  • Acute rejection

  • Infection

  • CMV infection

  • Malignancy

  • SCr (mg/dL)

Notes
  • Did not report number screened for eligibility or analysed

  • Number of patients discontinued treatment

    • No steroids group: switched to different immunosuppression: AZA + steroids (6), steroids added (12)

    • Maintenance group: switched to AZA + steroids (3)

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk 'A computer‐derived randomised blocks of varying size was generated and noted in a series of opaque envelopes held by the research pharmacist at each participating centre.'
Allocation concealment (selection bias) Low risk Stated 'opaque 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 Unclear risk Unclear whether ITT analysis performed and whether all patients have been followed up or accounted for
Selective reporting (reporting bias) Low risk Primary outcomes for this review reported
Other bias High risk The study was supported by Medical Research Council of Canada; Richard and Jean Ivey Fund, London, Ontario; Sandoz Ltd, Basel; the Micheal Fung Endowment Fund, London, Ontario; the University Hospital Transplant Research Fund, London, Ontario