drugset / Trial / NCT05174221
A Study of Mezagitamab in Adults With Primary Immunoglobulin A Nephropathy Receiving Stable Background Therapy
NaSingle-groupOpen-labelTreatment
Summary
This study will have two parts. The main aims are to: * check the side effects from mezagitamab. * check for long-term side effects from mezagitamab. Before starting the study, participants will be asked to provide a 24-hour urine sample. A few weeks later, if enrolled they will begin receiving a subcutaneous injection (under the skin) of mezagitamab once a week for 8 weeks then once every 2 weeks for 16 weeks. When treatment has ended, there will be a 24-week follow-up period. Participants who receive benefit from the treatment may continue in the second part of the study where they will be monitored for up to 96 weeks and possibly retreated for another 24 weeks.
Timeline
- Start
- 2022-08-16
- Primary completion
- 2025-12-15
- Completion
- 2025-12-15
Publications
- Ahmad SB, Jefferson JA. Targeting B Cells and Plasma Cells in Glomerular Disease. J Am Soc Nephrol. 2025 Jun 4;36(9):1844-1857. doi: 10.1681/ASN.0000000772.
- Mayer KA, Budde K, Diebold M, Halloran PF, Bohmig GA. Targeting CD38 in Antibody-Mediated Rejection. Transpl Int. 2025 May 15;38:14343. doi: 10.3389/ti.2025.14343. eCollection 2025.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mezagitamab | Monoclonal antibody | — | Subcutaneous |