Choi 2018.

Study characteristics
Methods	Study design: parallel RCT Study duration: June 2013 to May 2016 Duration of follow‐up: 48 weeks
Participants	Setting: multicentre Country: Korea Inclusion criteria: renal biopsy within last 12 months; ≥18 years; proteinuria > 8 g/day or proteinuria < 8 g/day and any 3 or more of the following: eGFR < 60 mL/min/1.73 m² Hypertension ≥140/90 mm Hg or ≥ 120/80 with antihypertensive drugs 24‐hour urinary protein > 5.0 g/day or spot UPCR > 5 g/g Serum albumin < 3 g/dL Selectivity index > 0.2 (urine IgG x serum albumin/serum IgG x urine albumin Baseline characteristics Mean SBP/DBP ± SD (mm Hg): 123.7 ± 17.2 / 76.5 ± 11.42 Mean proteinuria ± SD: 8.7 ± 4.9 g/24 hours Mean serum albumin ± SD: 24 ± 6 g/L Mean GFR ± SD: 78.9 ± 28.7 mL/min/1.73 m² Mean SCr ± SD: 1.1 ± 0.4 mg/dL Mean serum cholesterol ± SD: 15.29 ± 3.86 mmol/L Disease‐course (time since diagnosis) at immunosuppressive treatment initiation: < 12 months Co‐morbidities: DM (20.5%), hypertension (59.0%), microscopic haematuria (87.2%) Number: treatment group (21); control group (18) Mean age (years): treatment group (57.7), control group (52.7) Sex (M/F): treatment group (16/5); control group (9/9) Exclusion criteria: moderate to severe gastrointestinal disorder; history of allergy to MMF or CSA; acute or chronic allergy within 4 weeks; the presence of life‐limiting comorbid disorders such as malignancy or uncontrollable active infection; drug or alcohol addiction within 6 months; uncontrolled hypertension > 160/100 mm Hg; eGFR ≤ 30 mL/min/1.73 m²; absolute neutrophil count < 1500/mm³ or WCC < 2500/mm³; platelets < 100,000/mm³; > 3 times the normal liver function test values; pregnancy or lactation; immunosuppressive agents within 6 months for secondary MN with a systemic disorder; life expectancy < 1 year
Interventions	Treatment group MMF (oral) Prednisolone (oral) Control group: CSA (oral) Prednisolone (oral) Duration 46 weeks Co‐medications Most patients were treated with statins (94.9 %), ACEi/ARB (84.6%), proton pump inhibitor (48.7%)
Outcomes	Complete remission: decrease in proteinuria to ≤ 200 mg/day and a sustained serum albumin level ≥ 3.5 g/dL Partial remission: decrease in proteinuria to > 200 and < 3500 mg/day or a decrease > 50% compared to baseline eGFR Relapse Improvement of hypoalbuminaemia and hypercholesterolaemia at 48 weeks Proteinuria Side effects Relapse: proteinuria ≥ 3,500 mg/day after the achievement of partial or complete remission or an increase in proteinuria > 50% in patients in whom proteinuria had improved initially by > 50%
Notes	Funding source: Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI) funded by the Ministry of Health and Welfare, Republic of Korea (grant number HC15C1129, HI15C0001); drugs and placebo used in the study were provided by Hanmi Pharmaceutical, Co., Ltd. (Seoul, South Korea), which had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript Sample size; at least 28 patients in each group would be needed for 80% power assuming a 5% significance level. As a 10% screening failure and the dropout rate was estimated, 31 patients would finally need to be included in each group (does not state what % change in complete remission this is for)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Block randomisation technique, using SAS randomisation program, managed by statisticians in external department
Allocation concealment (selection bias)	Low risk	Sealed sequential numbered opaque envelopes
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No mention of any blinding, except that both drugs were provided as prepacked drugs in identical bottles
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information to permit judgement
Incomplete outcome data (attrition bias) All outcomes	Low risk	43 screened, 39 included, high drop‐out (5/18 and 9/21) however all randomised patients were included in analysis (intention‐to‐treat)
Selective reporting (reporting bias)	Low risk	Complete and partial remission are appropriate outcomes. However, improvement in hypoalbuminaemia and hypercholesterolaemia were not reported as secondary outcomes on clinicaltrials.gov but were reported in the trial
Other bias	Low risk	Drugs were provided free of charge by pharmaceutical company that however was not involved in the study in any other way