NA IgAN 1995.

Methods	Study design: parallel, 3‐arm RCT Time frame: not reported Duration of follow‐up: 24 months
Participants	Setting: multicentre (37 centres; 44 centres were described in study protocol) Country: USA Inclusion criteria: < 40 years, able to swallow 500 mg placebo tablet; eGFR ≥ 50 mL/min/1.73 m2; persistent severe proteinuria; biopsy‐proven IgAN within 3 years of entry Number (analysed/randomised): treatment group (not reported/33); control group 1 (not reported/32); control group 2 (not reported/31) Mean age ± SD (years): treatment group (24 ± 10); control group 1 (20 ± 10); control group 2 (21 ± 10) Sex (M): treatment group (70%); control group 1 (66%); control group 2 (65%) Exclusion criteria: SLE; HSP nephritis; abnormal liver function; pregnancy or unwilling to use appropriate contraception; diabetes; cataracts; aseptic necrosis of any bone; use of study agents in the 3 months prior to entry
Interventions	Treatment group Prednisone: 60 mg/m2 on alternate days for 3 months, 40 mg/m2 on alternate days for 9 months, 30 mg/m2 on alternate days for 12 months Control group 1 Fish oil: up to 4 g/d for 2 years Control group 2 Placebo: half received fish oil placebo and half received prednisone placebo Co‐interventions Not reported
Outcomes	Time to kidney failure (decrease in CrCl ≤ 60% baseline value) Adverse events
Notes	Funding: "Supported by National Institute of Diabetes and Digestive and Kidney Diseases grant R01 DK49368. Medications that were used in this trial were generously donated by Merck and Co. Inc. (enalapril), Pharmacia and Upjohn (prednisone [Deltasone] and matching placebo), and Pronova Biocare (Omacor and matching placebo)." 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	High 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. However, reporting of adverse events may have been influenced by knowledge of treatment allocation
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "72 completed 2 years of trial drugs and 18 patients exited prematurely. Six patients dropped out of the trial after randomisation but before the start of study drugs."
Selective reporting (reporting bias)	High risk	The primary outcome was changed between the protocol (CrCl < 70% of baseline value) and the final study publication (CrCl <of 60% of baseline value)
Other bias	High risk	Interim analyses were planned but not clearly reported. The methods for interim analyses were different in the protocol and the final study publication. Imbalance at baseline for level of proteinuria between study groups