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

  • Time frame: not reported

  • Follow‐up period: greater than 6 months

Participants
  • Setting: tertiary centre

  • Country: France

  • Children with SRNS (persistent nephrotic syndrome after 5 weeks or more of prednisone at 2 mg/kg/d); not stated whether children had initial or delayed steroid resistance

  • Number (chlorambucil/indomethacin): 15/15

  • Age: not reported

  • Sex (M/F): not reported

  • Histology

    • Chlorambucil group: MCD (5); FSGS (6); FSGS with mesangial proliferation (4)

    • Indomethacin group: MCD (4); FSGS (8); FSGS with mesangial proliferation (2)

  • Exclusion criteria: steroid responsive not reported

Interventions Chlorambucil group
  • 0.2 mg/kg/d for 6 months


Indomethacin group
  • 3 mg/kg/d for 6 months


Co‐interventions: not reported
Outcomes
  • Remission of nephrotic syndrome: definition not reported after at least 6 months

  • ESKD

Notes
  • Exclusions post randomisation but pre‐intervention: not 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 No blinding of investigators/participants; lack of blinding could influence management.
Blinding of outcome assessment (detection bias) All outcomes Unclear risk No information about how primary outcome was measured
Incomplete outcome data (attrition bias) All outcomes Unclear risk Data only available from conference proceedings
Selective reporting (reporting bias) Unclear risk Complete remission (no definition provided), ESKD
Other bias Unclear risk Funding source not stated
Data from conference proceedings