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. 2016 Oct 11;2016(10):CD003594. doi: 10.1002/14651858.CD003594.pub5
Methods
  • Study design: cross‐over RCT

  • Time frame: not reported

  • Follow‐up period: 3 months

Participants
  • Setting: tertiary centre

  • Country: USA

  • SRNS defined as proteinuria 40 mg/m2/h, or > 50 mg/kg/d and serum albumin < 25 g/L after 8 weeks of prednisone (2 mg/kg/d); not reported whether children had initial or delayed steroid resistance

  • Number: 8

  • Age: 3 to 18 years

  • Sex (M/F): 6/2

  • Histology: MCD (4); FSGS (4)

  • Exclusion criteria: not reported

Interventions CSA group
  • 5 mg/kg/d for 8 weeks adjusted to level ≤ 200 ng/mL


No treatment group
  • No treatment for 8 weeks


Co‐interventions
  • Not reported; no patient on prednisone during study

Outcomes
  • Complete remission at 8 weeks: not defined

  • Partial remission at 8 weeks: not defined

Notes
  • Exclusions post randomisation but pre‐intervention: none reported

  • Stop or end points/s: not reported

  • Additional data requested from authors: none

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information provided
Allocation concealment (selection bias) Unclear risk No information provided
Blinding of participants and personnel (performance bias) All outcomes High risk Participants/investigators not blinded; lack of blinding could influence management
Blinding of outcome assessment (detection bias) All outcomes Low risk Primary outcome was laboratory outcome based and unlikely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) All outcomes Low risk All patients followed up and accounted for
Selective reporting (reporting bias) Low risk Complete/partial remission/adverse effects reported
Other bias Unclear risk Funding source not reported