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

del Castillo 2005.

Methods
  • Study design: parallel RCT

  • Time frame: 2002 to 2004

  • Follow‐up period: 1 year

  • Primary endpoint: not reported

Participants
  • Country: Spain, Portugal

  • Setting: multicentre (16 centres)

  • First kidney transplant, no further inclusion criteria provided

  • Number (randomised/analysed): withdrawal group (70/70); maintenance group (72/72)

  • Mean age ± SD (years): withdrawal group (47 ± 11); maintenance group (47 ± 11)

  • Sex (female): withdrawal group (53%); maintenance group (26%)

  • Exclusion criteria: not reported

Interventions Treatment group
  • Steroid withdrawal 6 months after transplantation


Control group
  • Steroid maintenance


Baseline immunosuppression
  • CsA: not reported

  • MMF: not reported

  • Prednisone: not reported

Outcomes
  • Mortality

  • Graft loss

  • Acute rejection

  • Biopsy‐proven acute rejection

  • SCr (mg/dL)

  • CrCl (mL/min)

Notes
  • Did not report number screened for eligibility

  • 4 patients were excluded post randomisation but pre‐intervention because they did not fulfil the inclusion criteria

  • 2 control patients lost to follow‐up during the 12 months

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 Low risk ITT analysis performed; all patients followed‐up or accounted for
Selective reporting (reporting bias) Low risk Primary outcomes for this review reported
Other bias Unclear risk Funding source not reported; abstract data only