Table 1.
Clinical trials of novel/repurposed drugs in IgAN for which results are awaited
| Trial | Intervention | Inclusion criteria | Exclusion criteria | Trial design | Primary end point | Follow-up duration |
|---|---|---|---|---|---|---|
| Atacicept NCT02808429 |
Atacicept at varying doses vs placebo | Proteinuria 1–6 g/day Stabilised on RASi for 8 weeks |
Prior cyclophosphamide treatment Use of other immunosuppressants within 4 months |
Randomised, double-blind, placebo-controlled Phase II trial |
Incidence of adverse events | 180 weeks |
| BRIGHT-SC NCT02062684 |
Blisibimod vs placebo | Proteinuria 1–6 g/day Stabilised on RASi for 8 weeks |
Immunosuppressant use over last 6 months or corticosteroid use over last 3 months. Malignancy over last 5 years | Randomised, double-blind, placebo-controlled Phase II/III trial |
Reduction of proteinuria at 24 weeks | 104 weeks |
| SIGN NCT02112838 |
Fostamatinib at varying doses vs placebo | Stabilised on RASi for 90 days. BP < 130/80 Proteinuria > 1 g/day at diagnosis and > 0.5 g/day at second screening visit |
Recent use of corticosteroids, cyclophosphamide, mycophenolate mofetil, azathioprine or rituximab | Randomised, multicentre, double-blind, placebo-controlled, Phase II trial | Reduction of proteinuria at 24 weeks | 24 weeks |
| VELCADE NCT01103778 |
Bortezomib | Proteinuria > 1 g/day Stabilised on RASi for 4 weeks |
Peripheral neuropathy, history of cardiac problems, malignancy within last 3 years | Open-label, Phase IV trial | Reduction of proteinuria at 1 year | 1 year |
| ACTHAR NCT02282930 |
Acthar gel | Proteinuria > 1 g/day Stabilised on RASi for 3 months BP > 130/80 HSP patients included |
Crohn’s disease or celiac sprue Glucocorticoid treatment in last 3 months Immunosuppressive therapy in last 6 months Previous ACTH treatment History of malignancy History of cardiac or pulmonary disease |
Open-label, Phase III trial | Reduction in proteinuria at 1 year, stabilisation of eGFR at 1 year | 1 year |
| OMS721 NCT02682407 |
OMS721 vs placebo | Patients on immunosuppressive patients included, if on stable dose for 2 months Optimised RASi, BP < 150/90, Urine ACR > 600 mg/g |
Renal transplant History of malignancy Use of belimumab, rituximab, or eculizumab within last 6 months HSP within 2 years |
Randomised, double-blind, placebo-controlled, Phase II trial | Incidence of adverse events | 18 weeks |
| LNP023 NCT03373461 |
LNP023 vs placebo | Stabilised on RASi for 90 days eGFR ≥ 30, proteinuria ≥ 0.75 g/day |
Recent use of immunosuppression, history of drug/alcohol abuse, malignancy | Randomised, double-blind, placebo-controlled Phase IIa/IIb trial | Reduction of proteinuria at 90 days | 180 Days |
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. All trials, except SIGN trial, explicitly stated exclusion if evidence of significant glomerular/cortical scarring was present on biopsy
RASi renin–angiotensin system inhibition, IgAV IgA vasculitis/Henoch–Schonlein purpura