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
Chinese Adults With Kidney Disease
This is a Phase 2 study to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics of ADX-038 in adults with complement-mediated kidney diseases. The study will enroll Chinese adults with IgA nephropathy, complement 3 glomerulopathy (C3G) and immune complex membranoproliferative glomerulonephritis (IC-MPGN). The study will evaluate ADX-038 administered alone (Part A) and in combination with telitacicept (Part B).
Allogeneic CD19/BCMA CAR-T for B Cell-Related Autoimmune Disease
This is an exploratory, open-label, single-arm Phase 1 clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219C. QT-219C is a universal allogeneic chimeric antigen receptor T-cell (CAR-T) product targeting both CD19 and BCMA. The study targets subjects with refractory B-cell-related autoimmune diseases, including systemic lupus erythematosus (SLE), multi-drug resistant nephrotic syndrome (NS), IgA nephropathy (IgAN), systemic sclerosis (SSc), and ANCA-associated vasculitis (AAV) .The research is divided into two phases: a dose-escalation phase and a dose-expansion phase. Dose Escalation: Utilizes a standard "3+3" design to evaluate potential recommended dose(RD) and identify dose-limiting toxicities (DLTs) .Treatment Procedure: Eligible subjects will receive a lymphodepleting conditioning regimen followed by a single intravenous infusion of QT-219C .Primary Objectives: The primary goals are to evaluate the safety profile, including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and to assess clinical response rates at 90 days post-infusion .Follow-up: Subjects will be monitored for pharmacokinetics (cell expansion), pharmacodynamics (B-cell depletion), and long-term safety for up to two years .
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