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. 2020 Mar 12;2020(3):CD003965. doi: 10.1002/14651858.CD003965.pub3

Ni 2005.

Methods
  • Study design: parallel, 2‐arm RCT

  • Time frame: not reported

  • Duration of follow‐up: 24 months

Participants
  • Setting: multicentre (number of sites not reported)

  • Country: China

  • Inclusion criteria: progressive biopsy‐proven IgAN; proteinuria > 1.0 g/day or SCr > 178 µmol/L and < 250 µmol/L

  • Number (analysed/randomised): treatment group (unclear/53); control group (unclear/49)

  • Mean age ± SD (years): not reported

  • Sex (M/F): not reported

  • Exclusion criteria: not reported

Interventions Treatment group
  • Leflunomide: 40 mg/day for 3 days followed by 20 mg/d for 12 months

  • Prednisone: 0.8 mg/kg tapered to 10 mg/kg for 12 months


Control group
  • Prednisone: 1 mg/kg/day tapered to 10 mg/day for 12 months


Co‐interventions
  • not reported

Outcomes
  • Remission of proteinuria

  • SCr

  • GFR

  • Adverse events

Notes
  • Abstract‐only publication

  • Funding: not reported

  • Trials registration identification number: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Blinding of outcome assessment not specifically reported. Key outcomes were objective laboratory measures and were unlikely to be affected by any knowledge of treatment allocation. However, reporting of adverse events may have been influenced by knowledge of treatment allocation
Incomplete outcome data (attrition bias) 
 All outcomes High risk Preliminary reports, unsure of final number enrolled. 73/102 participants completed 12 months, 28/102 completed 24 months
Selective reporting (reporting bias) High risk Data for outcomes such as ESKD, death (any cause), and malignancy were not reported
Other bias Unclear risk Insufficient information to permit judgement