Felzartamab for IgA Nephropathy: Final Results of the IGNAZ Study
Bibliographic record
Abstract
Background: Felzartamab is a monoclonal antibody that binds to CD38 on plasma cells–the likely source of pathogenic Gd-IgA1 and autoantibodies in IgA nephropathy (IgAN). The randomized, double-blind, placebo-controlled phase 2a IGNAZ study assessed the efficacy and safety of felzartamab vs placebo (PBO) in patients with IgAN. Final 24-month data are reported. Methods: Patients aged 18−80 years with biopsy-confirmed IgAN, proteinuria ≥1.0 g/d (≥0.5 g/d for Japanese patients), and eGFR ≥30 mL/min per 1.73m2 using renin-angiotensin inhibitors ≥3 months were randomized 1:1:1:1 in Part 1 to PBO (n=12) or felzartamab in 1 of 3 arms: 2 doses in 15 days (M1; n=12), 5 doses in 2 months (M2; n=11), and 9 doses in 5 months (M3; n=13). In Part 2, 6 Japanese patients received open-label M3. Results: Patients were 67% men, with a mean age of 41.6 years, UPCR of 1.7 g/g, and eGFR of 74.6 mL/min per 1.73m2. In Part 1, 40/48 patients completed treatment. Treatment with felzartamab led to rapid, clinically meaningful reductions in UPCR vs PBO, with the greatest effect in the M3 arm (Fig A). Mean eGFR declined less in the felzartamab arms vs PBO (Fig B). Among felzartamab arms, IgA reductions were rapid and durable (lasting 19 months after the last dose); IgG recovered by 6−9 months. Efficacy in Part 2 was similar to that of the Part 1 M3 arm. Treatment-emergent AEs were typically grade 1 or 2 and were not dose-dependent. The most common treatment-related AE was infusion-related reaction (IRR), usually on dose one. There was one treatment-related serious AE of IRR. Five patients discontinued felzartamab for IRR/hypersensitivity. The infection incidence was similar across felzartamab arms; all were grade 1 or 2 and non-serious. Conclusion: Felzartamab was generally well tolerated and led to sustained proteinuria reduction and reduced eGFR decline vs PBO, indicating potential disease modification in patients with IgAN. Investigation of felzartamab in patients at high risk for loss of kidney function is warranted. Funding: Commercial Support - Human Immunology Biosciences, Inc., a Biogen Company
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.006 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.003 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".