Table 2.

Clinical trials of novel/repurposed drugs in IgAN for which results have been published

Trial	Intervention	Inclusion criteria	Exclusion criteria	Trial design	Primary end point	Follow-up	Sample size	Outcome
Avacopan NCT02384317	Avacopan 30 mg twice daily	After 4 weeks of optimised RASi eGFR > 60 eGFR > 45 if decline < 10 mL/min/1.73 m2 over prior 24 weeks Urine PCR > 1 g/g	Proteinuria > 8 g/day, Malignancy within 5 years, cardiac disease, immunosuppression in last 24 weeks. HSP within last 2 years	Open-label Phase II trial	Incidence of adverse events	12 weeks	7	Reduction of proteinuria in 6 of 7 patients
Rituximab NCT00498368	Rituximab + supportive care vs supportive care alone	After 2 months of optimised RASi Proteinuria ≥ 1 g/day BP < 130/80 HSP included	eGFR < 30 > 6 months of steroids > 50% glomerular senescence or cortical scarring, history of Crohn’s disease or celiac sprue	Randomised, open-label, multicentre, Phase IV trial	Proteinuria and eGFR at 12 months	12 months	34, American	No effect on end points
NEFIGAN NCT01738035	TRF-budesonide 8 mg or 16 mg + supportive care vs supportive care alone	After 6 months of optimised RASi Urine PCR ≥ 0.5 g/g OR urine protein ≥ 0.75 g/24 h eGFR ≥ 45, BP ≤ 160/100	Immunosuppression over previous 24 months, or at any time for IgAN Renal transplant, diabetes, malignancy over last 3 years	Randomised, multicentre, double-blind, placebo-controlled, Phase II trial	Urine PCR at 9 months and 12 months	12 months	149, European	Reduction in urine PCR achieved by budesonide

All RCTs required adult patients to have biopsy proven IgAN as part of their inclusion criteria, and excluded patients with secondary IgAN, liver disease, infections, and pregnant/breast feeding women. The rituximab trial explicitly stated exclusion of if evidence of significant glomerular/cortical scarring was present on biopsy

RASi renin–angiotensin system inhibition