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

Cao 2008.

Methods

  • Study design: parallel, 2‐arm RCT

  • Time frame: not reported

  • Duration of follow‐up: 6 months
Participants

  • Setting: single centre

  • Country: China

  • Inclusion criteria: progressive IgAN (renal biopsy proven newly with proteinuria > 1.0 g/d, plus Lee SMK grade II‐V and/or SCr between 178 and 250 µmol/L)

  • Number (analysed/randomised): treatment group (not reported/18); control group (not reported/18)

  • 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 6 months

  • Prednisone: 0.8 mg/kg/day tapered to10 mg/d for 6 months


Control group

  • Prednisone: 1 mg/kg/day tapered to 10 mg/day for 6 months


Co‐interventions

  • Not reported
Outcomes

  • Proteinuria

  • SCr

  • Urinary V‐CAM‐1
Notes

  • Conference abstract

  • Funding source: 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 There was no report of blinding. As the treatments were physically different, it was likely that participants and investigators were aware of treatment allocation
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Outcome assessment was not reported. However, the study outcomes of interest were objectively measured, therefore this was adjudicated as low risk of bias
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Selective reporting (reporting bias) High risk There was no pre‐specified protocol identified for this study. The study did not report extractable data for the key outcomes that would be expected for a study of this type (e.g., death (any cause), GFR loss, infection, malignancy)
Other bias Unclear risk Insufficient information to permit judgement. Methods of randomisation, baseline characteristics were not reported to assess quality of randomisation