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

Kanno 2003.

Methods
  • Study design: parallel, 2‐arm RCT

  • Time frame: not reported

  • Duration of follow‐up: 3 years

Participants
  • Setting: single centre

  • Country: Japan

  • Inclusion criteria: biopsy‐proven IgAN, aged 12 to 65 years

  • Number (analysed/randomised): treatment group (6/8); control group (4/7)

  • Mean age ± SD (years): treatment group (30 ± 5); control group (37 ± 5)

  • Sex (M/F): treatment group (7/1); control group (5/2)

  • Exclusion criteria: not reported

Interventions Treatment group
  • Prednisolone 0.5 mg/kg/day for approximately 1 month, when a 10% taper was instituted until the dose reached 0.12 mg/kg/day; for 36 months


Control group
  • Warfarin: 5 mg given for the first 2 days with further doses adjusted according to the value of the thrombotest, targeting around 30%


Co‐interventions
  • Not reported

Outcomes
  • Urinary protein excretion

  • SCr

Notes
  • Funding: not reported

  • Trials registration identification number: not applicable

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 Low 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
Incomplete outcome data (attrition bias) 
 All outcomes High risk 5/15 patients did not complete study (2 in the treatment group and 3 in the control group)
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)
Other bias Low risk The study appears to be free of other sources of bias