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

Chen 2002.

Methods
  • Study design: parallel, 2‐arm RCT

  • Time frame: not reported

  • Duration of follow‐up: 18 months

Participants
  • Setting: single centre

  • Country: China

  • Inclusion criteria: severe IgAN, Lee SMK grade IV‐V, with urinary protein >2.0 g/d, SCr < 355.2 µmol/L

  • Number (analysed/randomised): treatment group (not reported/31); control group (not reported/31)

  • Mean age ± SD (years): not reported

  • Sex (M/F): not reported

  • Exclusion criteria: not reported

Interventions Treatment group
  • MMF 1.0 g/d (body weight <50 kg) or 1.5 g/d (body weight >50 kg), reduced to 0.75 to 1.00 g/d after 6 months, and maintained at 0.5 to 0.75 g/d after 12 months of treatment


Control group
  • Prednisone: 0.8 mg/kg/day


Co‐interventions
  • Not reported

Outcomes
  • Proteinuria

  • Plasma albumin, serum cholesterol and triglycerides

  • Adverse events

Notes
  • Conference abstract

  • Trials registration identification number: not reported

  • 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 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. Reporting of adverse events may have been influenced by knowledge of treatment allocation
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