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Relevant publications
What moved this fortnight: the first China-cohort interim readout of sibeprenlimab's Phase 3 VISIONARY trial (61.9% placebo-adjusted proteinuria reduction), an ISN expert consensus on complement therapeutics in C3G & IgAN, and a first head-to-head-style network meta-analysis across the BAFF/APRIL class. On the trials side, 10 IgAN programs touched their registrations, and Roche's sefaxersen Phase 3 reaches primary completion Aug 31 — the next material catalyst.
Top signals ranked by clinical materiality
1
Sibeprenlimab Ph3 VISIONARY — China-cohort interim: 61.9% placebo-adjusted proteinuria reduction
First regional interim from the pivotal program behind the recently approved anti-APRIL agent; reinforces class-leading antiproteinuric effect in an East-Asian population.
2
ISN Forum on Complement Therapeutics in C3G & IgAN — consensus outcomes
Expert guidance on where complement inhibitors fit in real-world practice — directly relevant to positioning and medical education planning.
3
BAFF/APRIL-pathway inhibitors vs placebo: systematic review + network meta-analysis (7 RCTs, n=1,590)
First cross-class ranking of telitacicept, atacicept and sibeprenlimab: consistent proteinuria reduction (SMCR −0.73), sibeprenlimab highest exploratory P-score; fewer serious AEs on active treatment.
4
Felzartamab preserves humoral immunity and vaccine response in IgAN
Anti-CD38 safety differentiation ahead of PREVAIL Ph3 readouts — a likely talking point for B-cell-depletion comparisons.
5
Nefecon vs systemic corticosteroids — real-world comparative study (n=82)
Scarce direct RWE: comparable antiproteinuric efficacy, numerically fewer severe infections and steroid-related AEs with targeted-release budesonide.
Clinical & therapy 9 further items
- Practice variation in IgAN — editorial: the field is evolving faster than consensus; positioning context for newly approved agents. Kidney360 · doi:10.34067/KID.0000001343
- Telitacicept meta-analysis (8 studies, 459 pts) — pooled efficacy in IgAN. Front Med · doi:10.3389/fmed.2026.1894514
- Endothelin receptor antagonists in resistant HTN and proteinuric CKD — sparsentan/atrasentan/zibotentan positioning review. J Clin Hypertens · doi:10.1111/jch.70353
- Finerenone in IgAN — 12-month real-world study; off-label MRA signal. Renal Failure · doi:10.1080/0886022X.2026.2681246
- Finerenone after RASi discontinuation — multicentre retrospective cohort. Diabetes Obes Metab · doi:10.1111/dom.71225
- Telitacicept vs glucocorticoids vs Nefecon — real-world comparative letter. Drug Des Devel Ther · doi:10.2147/DDDT.S639608
- Nefecon US real-world case series in Asian-American patients — adherence and course-completion gaps. Clin Nephrol · doi:10.5414/CN112036
- What constitutes disease modification in IgAN? — regulatory-relevant framing letter. Clin Kidney J · doi:10.1093/ckj/sfag265
- C5-targeted GalNAc siRNA — sustained efficacy in NHP IgAN model; early pipeline signal. Mol Ther · doi:10.1016/j.ymthe.2026.08.022
Research radar 18 items — headlines
- Hematuria as prognostic marker — meta-analysis (Vertex-authored) doi:10.3389/fneph.2026.1899597 · hemoglobinuria as activity marker, 441-pt cohort doi:10.1016/j.kint.2026.07.021 · urinalysis-based risk model in 18k+ patients doi:10.3389/fneph.2026.1826486
- Complement pathway review mapped to MEST-C and drug targets doi:10.3389/fmed.2026.1896069 · NETs/cGAS-STING injury pathway doi:10.1016/j.bcp.2026.118354 · plasma-proteomics endotypes doi:10.3390/cells15151373
- Nefecon gut-microbiota differentiation doi:10.3389/fimmu.2026.1856526 · deep-learning glomerular morphometry added to the International IgAN Prediction Tool doi:10.3389/fimmu.2026.1910367 · Crohn's–IgAN shared-genetics MR doi:10.3389/fimmu.2026.1905767
- Urinary exosomal miRNA diagnostics — case-control, non-invasive biomarker panel (AUC > 0.8) Recovered by recall audit World J Nephrol · doi:10.5527/wjn.119882 · arginine-metabolism key genes (ARG1/ARG2) via scRNA-seq Recovered by recall audit Front Immunol · doi:10.3389/fimmu.2026.1888069
- Plus 7 further mechanistic/biomarker items in the run record.
Trials activity 10 IgAN registrations updated in window · CT.gov
| Sponsor / Program | Phase | Status | N | Note |
|---|---|---|---|---|
| Roche — sefaxersen NCT05797610 | Ph3 | Active, not recruiting | 459 | Primary completion Aug 31, 2026 — imminent |
| Takeda — mezagitamab (TAK-079) NCT06963827 | Ph3 | Recruiting | 347 | 176 sites |
| Biogen — felzartamab PREVAIL NCT06935357 | Ph3 | Recruiting | 454 | 258 sites |
| Otsuka — sibeprenlimab pediatric NCT07770815 | Ph3 | Not yet recruiting | — | Start 2026-09-30 |
| Novartis — zigakibart OLE NCT06858319 | Ph3 | Recruiting | 220 | Open-label extension |
| Jade Biosciences — JADE101 JUNIPER NCT07541287 | Ph2 | Recruiting | 30 | Anti-APRIL entrant |
| argenx — ARGX-121 NCT07773727 | Ph2 | Not yet recruiting | — | Start 2026-10-15 |
| MMF in refractory IgAN (Bangladesh) NCT07785128 · complement-severity observational (Strasbourg) NCT05234463 · Ruijin IgAN database NCT04858724 | Ph2/Obs | Investigator-initiated / registry activity | ||
Preprints (1 relevant)
IgA1 hinge-region O-glycoform signatures in pediatric IgA vasculitis — medRxiv, Aug 24 · doi:10.64898/2026.08.21.26361008. Adjacent to IgAN (shared Gd-IgA1 biology); flagged for reader judgment on IgAV adjacency.
Regulatory
No new IgAN approvals in window. Recent context: sibeprenlimab (VOYXACT) accelerated approval and atacicept approval earlier in 2026 — both now anchor the practice-variation debate (see Top signal 2 and the Kidney360 editorial).