Frisch 2005.

Methods	Study design: parallel, 2‐arm RCT Time frame: recruitment between August 2000 and May 2003; follow‐up stopped July 2003 Duration of follow‐up: 1 year treatment completion, total follow‐up was 2 years
Participants	Setting: single centre Country: USA Inclusion criteria: biopsy‐proven IgAN; proteinuria >1 g/day plus at least two of the following risk factors: male sex, hypertension > 150/90 mmHg, CrCl < 80 mL/min, severe lesions on biopsy Number (analysed/randomised): treatment group (17/17); control group (15/15) Mean age, range (years): treatment group (39, 19 to 72); control group (37, 22 to 59) Sex (M/F): treatment group (16/1); control group (11/4) Exclusion criteria: aged < 18 or > 76 years; pregnant females and females unwilling to use contraception; presence of malignancy, infection, liver disease or SLE, HSP or other serious systemic disease; CrCl ≤ 20 mL/min; presence of other diagnosis on renal biopsy; received corticosteroids or other immunosuppressive agents < 6 months prior to randomisation; > 50% active crescents on biopsy
Interventions	Treatment group MMF: 1000 mg twice/day for 52 weeks Control group Placebo for 52 weeks Co‐interventions All patients received an ACEI or an ARB, or both at study entry and other antihypertensives were included as needed to maintain BP at optimal levels (target 130/80 mmHg). Due to their uncertain efficacy but lack of toxicity, patients were allowed to take fish oils at their own or at their physician’s discretion
Outcomes	ESKD requiring KRT 50% increase in SCr SCr decrease 0.5 mg/dL Adherence Remission of proteinuria death (any cause) Serious infection Adverse events
Notes	Study terminated after second scheduled interim analysis Funding: "This study was supported in part by Roche Pharmaceuticals and the Glomerular Center at Columbia University as an investigator‐initiated study (J.L. and G.A.), the NKF of NY/NJ under the Fred C. Trump Fellowship (J.L.), a KUFA fellowship (J.R.) and the Kidney Foundation of Canada (G.F.)." Trials registration identification number: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomised using permuted blocks of four. Insufficient information to permit judgement
Allocation concealment (selection bias)	Unclear risk	Known only to the research pharmacy. Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Patients and physicians were blinded to the therapy by use of identical capsules. Double‐blind study
Blinding of outcome assessment (detection bias) All outcomes	High risk	Not reported. Key outcomes were objective laboratory measures or clinical events and were unlikely to be affected by any knowledge of treatment allocation. Reporting of adverse events may have been influenced by knowledge of treatment allocation
Incomplete outcome data (attrition bias) All outcomes	Low risk	All patient data were available
Selective reporting (reporting bias)	Low risk	All relevant outcomes were reported
Other bias	High risk	The study was terminated early after the second scheduled interim analysis done by the independent study monitor revealed a trend towards a worse outcome in the MMF group that would have made it highly unlikely to show a benefit for MMF given our rate of recruitment and our target sample size. Follow‐up stopped in July 2003