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

Kacar 2004.

Methods
  • Study design: parallel RCT

  • Time frame: not reported, but before 2004

  • Follow‐up period: not reported

  • Primary endpoint: not reported

Participants
  • Country: Turkey

  • Setting: single centre

  • Kidney transplantation > 2 years ago; stable kidney function

  • Number (randomised/analysed): withdrawal group (31/31); maintenance group (30/30)

  • Mean age ± SD (years): not reported

  • Sex (female): not reported

  • Exclusion criteria: acute rejection within last 6 months

Interventions Treatment group
  • Steroid withdrawal > 2 years after transplantation


Control group
  • Steroid maintenance


Baseline immunosuppression
  • No further information provided

Outcomes
  • Mortality

  • Graft loss

  • Acute rejection

  • SCr

Notes
  • Did not report number screened for eligibility

  • Number of patients discontinued treatment

    • Withdrawal group: reintroduced steroids because of discontinuation of AZA, increase of SCr or acute rejection (7)

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 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; total number of patients by group for outcomes not reported
Selective reporting (reporting bias) Low risk Primary outcomes for this review reported
Other bias Unclear risk Funding source not reported
Abstract‐only publication