FONT II 2011.

Methods	Study design: parallel RCT (phase 2) Time frame: July 2009 to February 2013 Follow‐up period: 26 weeks
Participants	Setting: multicentre Country: USA Adults and children aged 1 to 51 years with biopsy‐confirmed primary FSGS or documentation of disease causing mutation; initial steroid resistance and resistance to at least one other immunosuppressive agent; persistent proteinuria (UP/C > 1.0 g/g); eGFR > 40 mL/min/1.73 m2; patients off all immunosuppressive agents (except low dose prednisolone) for at least 4 weeks Number (enrolled/completed): adalimumab group (7/6); galactose group (7/7); control group (7/6) Mean age: 14.7 years (IQR 13.0, 20.8 years) Sex (M/F): 9/12 Exclusion criteria: secondary FSGS; allergic to the study medications; HCT < 27%; uncontrolled hypertension; DM; CHF or MI; active or serious infection; cirrhosis or chronic active liver disease; history of significant GI disorder; organ transplantation; history of malignancy/abnormal pap smear; participation in another therapeutic trial within 30 days before randomisation; lactation, pregnancy, child‐bearing age and refused birth control; prior therapy with study interventions; therapy with other immunosuppressive agents within 30 days and RTX within 12 weeks
Interventions	Adalimumab group 24 mg/m2 SC (maximum 40 mg/dose) on alternate weeks for 26 weeks Galactose group 0.2 g/kg per dose orally twice a day, dissolved in 15 to 30 mL of water and ingested 15 to 30 min before breakfast and dinner for 26 weeks. The maximum single dose was 15 g Control group Conservative therapy as set out below for 26 weeks Co‐interventions in all participants Lisinopril (maximum dose 10 mg for participants < 40 kg; 20 mg for participants ≥ 40 kg) Losartan (maximum dose 25 mg for participants < 40 kg; 50 mg for participants ≥ 40 kg) Atorvastatin (maximum dose 10 mg for participants < 40 kg; 20 mg for participants ≥ 40 kg)
Outcomes	Primary outcome: preservation of GFR and >50% reduction in proteinuria Number with >50 % reduction in proteinuria eGFR preservation Adverse events
Notes	Data on method of randomisation requested but no response from authors received
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Study described as randomised; method of randomisation not reported
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	Primary outcomes are laboratory based and unlikely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants accounted for in analyses
Selective reporting (reporting bias)	Low risk	Expected outcomes reported
Other bias	Low risk	Funding from the National Institutes of Health—National Institute of Diabetes, Digestive, and Kidney Diseases, grant DK70341 (HT).Abbott Laboratories provided adalimumab for use in the project. Supported by NephCure Kidney International