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

Yamauchi 2001.

Methods

  • Study design: RCT

  • Time frame: September 1990 to December 1997

  • Duration of follow‐up: mean 41 months
Participants

  • Setting: not reported

  • Country: Japan

  • Inclusion criteria: patients diagnosed as primary IgA nephropathy. They had a histological diagnosis of IgA nephropathy with immunofluorescence showing mesangial IgA deposits

  • Number (analysed/randomised): overall (not reported/37); treatment group (not reported/17); control group (not reported/20)

  • Mean age ± SD (years): overall (not reported); treatment group (not reported); control group (not reported)

  • Sex (M/F): overall (13/24); treatment group (not reported); control group (not reported)

  • Exclusion criteria: not reported
Interventions Treatment group

  • IV methylprednisolone: 1g daily for 3 consecutive days

  • Oral prednisolone: for 12 months


Control group

  • No steroid treatment


Co‐interventions

  • Not reported
Outcomes

  • ESKD

  • Renal survival (doubling of SCr)

  • Urinary protein excretion

  • Mesangial cell proliferation

  • Mesangial matrix

  • Cellular crescents
Notes

  • Conference abstract

  • 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 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