IgA nephropathy is the most common primary glomerulonephritis worldwide, caused by abnormal IgA1 antibodies that deposit in the kidneys and trigger inflammation, leading to blood in the urine, proteinuria, and in many patients, progressive loss of kidney function over decades. Up to 40% of patients reach kidney failure within 20 years of diagnosis.
What's actually going on in research
Until recently, treatment was limited to blood pressure control, renin-angiotensin system blockers, and sometimes immunosuppression. A major shift is underway: sparsentan received accelerated approval in 2023, and budesonide targeted-release has been approved for some patients. Trials are testing complement inhibitors, APRIL and BAFF pathway blockers, and other immunological targets that address the root cause of aberrant IgA production and deposition.
Complement pathway inhibitors
Iptacopan, a factor B complement inhibitor, and other complement-blocking drugs are in late-stage trials after showing significant reductions in proteinuria, targeting the inflammation cascade triggered by IgA deposits.
APRIL and BAFF blockade
Zigakibart and sibeprenlimab, monoclonal antibodies blocking APRIL and BAFF cytokines that drive aberrant IgA production, are showing promising proteinuria reductions in phase 2 and 3 trials.
Endothelin and angiotensin blockade
Sparsentan, a dual endothelin and angiotensin receptor blocker, is now approved with accelerated status and is being studied for full approval based on long-term kidney function outcomes.
What to know before you search
Eligibility depends on the level of proteinuria, kidney function, biopsy findings, and prior use of renin-angiotensin system blockers.
What types of trials are currently open
- Complement inhibitor trials — Testing factor B, factor D, and C5 inhibitors to block kidney inflammation triggered by IgA deposits.
- APRIL/BAFF pathway trials — Evaluating monoclonal antibodies that reduce abnormal IgA production at its B cell source.
- Dual receptor blocker trials — Studying sparsentan and related drugs that target both endothelin and angiotensin pathways.
- Immunosuppression trials — Refining the role of corticosteroids and other immunosuppressants in high-risk IgA nephropathy.
- Biomarker trials — Identifying galactose-deficient IgA1 levels and other markers that predict progression and treatment response.
Recently added Iga Nephropathy trials
A Study to Evaluate the Long-Term Safety and Efficacy of HSK39297 Tablets in Primary IgA Nephropathy
This is a Phase II, multicenter, open-label study. Eligible subjects who have completed the HSK39297-202 study will be enrolled.Starting dose is 200 mg QD.Dose may be increased to 300 mg QD after 8-12 weeks of stable 200 mg QD therapy if 24-h urine protein excretion (UPE) remains \>1 g/24 h and no Grade ≥3 treatment-related adverse events (AEs) occur.After the treatment period, subjects will enter the 4-week safety follow-up period.
Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases
This is a Phase 1b/2, open-label, multi-center study evaluating the therapeutic potential and safety of the investigational drug EVER001 in adults with FSGS, MCD, or IgAN. EVER001 acts on multiple immune pathways without directly affecting T cells or depleting B cells (both are lymphocytes). The study will be conducted at \~30 centers in China, enrolling 45 participants aged 18-75 years (15 per indication). The IMP is a 100 mg oral capsule, dosed at 200 mg twice daily (2 capsules per dose, 4 daily) for 52 weeks.
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