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

Aswad 1998.

Methods
  • Study design: parallel RCT

  • Time frame: not reported

  • Follow‐up period: not reported

  • Primary endpoint: not reported

Participants
  • Country: USA

  • Setting: single centre

  • Living kidney transplant, no further inclusion criteria provided

  • Number analysed: withdrawal group (11); maintenance group (10)

  • Mean age ± SD (years): not reported

  • Sex: not reported

  • Exclusion criteria: not reported

Interventions Treatment group
  • Steroid withdrawal 6 months after transplantation


Control group
  • Steroid maintenance


Baseline immunosuppression
  • TAC: adjusted to trough levels month 1: 10 to 15 ng/mL; thereafter: 5 to 10 ng/mL

  • AZA: no further information provided

  • Prednisone: no further information provided

Outcomes
  • Mortality

  • Graft loss

  • Acute rejection

  • SCr

Notes
  • Did not report the number screened for eligibility or randomised

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Stated 'randomly assigned' 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 Number of patients by group not reported for outcomes; unclear if ITT analysis performed
Selective reporting (reporting bias) Low risk Primary outcomes for this review reported
Other bias Unclear risk Funding source not reported
Abstract‐only publication