Skip to main content
. 2020 Mar 12;2020(3):CD003965. doi: 10.1002/14651858.CD003965.pub3

Katafuchi 2003.

Methods
  • Study design: parallel, 2‐arm RCT

  • Time frame: July 1991 to September 1995

  • Duration of follow‐up: 60 months

Participants
  • Setting: single centre

  • Country: Japan

  • Inclusion criteria: biopsy‐proven IgAN; aged < 60 years; SCr ≤ 1.5 mg/dL

  • Number (analysed/randomised): treatment group (43/49); control group (47/54)

  • Mean age ± SD (years): treatment group (33.6 ± 13.4); control group (32.5 ± 10.8)

  • Sex (M/F): treatment group (15/28); control group (22/25)

  • Exclusion criteria: previous treatment with steroids; pregnancy; HPS; SLE; DM; neoplasia; active peptic ulcer disease; viral hepatitis; other infection

Interventions Treatment group
  • Prednisolone: 20 mg/day for 1 month, 15 mg/day for 1 month, 10 mg/day for 1 month, 7.5 mg/day for 3 months, 5 mg/day for 18 months

  • Dipyridamole: 150 or 300 mg/day


Control group
  • Dipyridamole: 150 or 300 mg/day


Co‐interventions
  • Not reported

Outcomes
  • ESKD

  • Urinary protein excretion

  • SCr

  • CrCl

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 6/49 participants lost to follow up in intervention group; 7/54 participants lost to follow up in 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), malignancy, infection)
Other bias Low risk The study appears to be free of other sources of bias