| Methods |
Study design: parallel, 2‐arm RCT Time frame: January 1994 to December 1998 Duration of follow‐up: 2 years |
| Participants |
Setting: multicentre (20 sites) Country: Japan Inclusion criteria: aged ≤ 15 years with IgAN; no previous treatment with corticosteroids or immunosuppressive drugs; sufficient renal biopsy tissue available for histologic evaluation (minimum of 10 glomeruli) Number (analysed/randomised): treatment group (39/40); control group (39/40) Mean age ± SD (years): treatment group (11.5 ± 3.2); control group (11.1 ± 2.8) Sex (M/F): treatment group (22/18); control group (21/19) Exclusion criteria: not reported |
| Interventions |
Treatment group
Prednisone: 2 mg/kg/day in 3 divided doses for 4 weeks, then single dose of 2 mg/kg on alternate days for 4 weeks, 1.5 mg/kg on alternate days for 4 weeks; 1 mg/kg on alternate days for 21 months AZA: 2 mg/kg/day for 2 years Oral warfarin: single morning dose to maintain the thrombotest at 30% to 50% for 23 months Dipyridamole: 5 mg/kg/d 3 divided doses for a total dose of not more than 400 mg/day for 24 months
Control group
Co‐interventions
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| Outcomes |
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| Notes |
Funding: "This study was supported in part by Health and Labor Sciences Research Grants (Research on Children and Families) by Japanese Ministry of Health Labor and Welfare." Trials registration identification number: 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 |
"Sealed envelope technique in blocks of four." |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Open‐label study |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Two independent investigators who were blinded to the treatment status reviewed the second biopsies. 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 |
Low risk |
1/40 participants did not complete study from each treatment group |
| Selective reporting (reporting bias) |
High risk |
Key outcomes expected for this type of study (death (any cause) and ESKD) were not reported |
| Other bias |
Low risk |
The study appeared to be free of other sources of bias |
