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

Hou 2017.

Methods
  • Study design: parallel, 2‐arm RCT

  • Time frame: December 2010 to April 2013

  • Duration of follow‐up: 12 months

Participants
  • Setting: multicentre (5 sites)

  • Country: China

  • Inclusion criteria: biopsy‐proven IgAN, with active proliferative lesions (cellular and fibrocellular crescents, endocapillary hypercellularity, or necrosis), proteinuria with protein excretion ≥ 1.0 g/24 hours, and eGFR > 30 mL/min/1.73 m2

  • Number (analysed/enrolled): treatment group (86/87); control group (88/89)

  • Mean age, range (years): treatment group (30.5, 25 to 37); control group (32.5, 25 to 43)

  • Sex (M/F): treatment group (39/47); control group (38/50)

  • Exclusion criteria: IgAN from a secondary cause and with eGFR < 30 mL/min/1.73 m2

Interventions Treatment group
  • MMF: 1.5 g/day for 6 months


Control group
  • Prednisone: 0.8 to 1 mg/kg/day for 2 months and then tapered by 20% each month for the next 4 months


Co‐interventions
  • Prednisone (0.4 to 0.6 mg/kg/day) for 2 months and then tapered by 20% each month for the next 4 months and stopped at 6 months

Outcomes
  • Complete remission (proteinuria becoming undetectable, with a stable SCr level (defined as not > 25% above the baseline)

  • Partial remission (protein excretion > 0.4 to < 1.0 g/24 hours, serum albumin level ≥ 35 g/L, and stable SCr level (defined as not > 25% above baseline)

  • Relapse (remission (complete or partial) followed by proteinuria with protein excretion > 1.0 g/24 hours on 2 consecutive measurements)

Notes
  • The trial was funded by the National Key Technology R&D Program (2013BAI09B04, 2015BAI12B05)

  • Trials registration identification number: nCT01269021

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Hangzhou Tigermed Consulting Co Ltd created the randomisation list
Allocation concealment (selection bias) Unclear risk Sequentially numbered concealed envelopes containing group assignments were provided to investigators. Not stated if envelopes were opaque
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk The outcomes were adjudicated by an independent Clinical End Points Committee, blinded to the treatment regimen
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 1/87 in treatment group not included in primary analysis. 1/89 in control group not included in primary analysis
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), ESKD, GFR loss, infection)
Other bias Low risk The study appears to be free of other sources of bias