drugset / Trial / NCT04287985
Safety and Efficacy Study of VIS649 for IgA Nephropathy
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of VIS649 in participants with immunoglobulin A (IgA) Nephropathy (IgAN)
Timeline
- Start
- 2020-07-20
- Primary completion
- 2023-05-19
- Completion
- 2023-06-18
Publications
- Results Mathur M, Barratt J, Chacko B, Chan TM, Kooienga L, Oh KH, Sahay M, Suzuki Y, Wong MG, Yarbrough J, Xia J, Pereira BJG; ENVISION Trial Investigators Group. A Phase 2 Trial of Sibeprenlimab in Patients with IgA Nephropathy. N Engl J Med. 2024 Jan 4;390(1):20-31. doi: 10.1056/NEJMoa2305635. Epub 2023 Nov 2.
- McCafferty K, Barratt J, Suzuki Y, Liew A, Rizk DV, Chacko B, Kooienga L, Lafayette R, Wong MG, Pasetti MF, Shriver MC, Follman K, Moc Willeford C, Sahay M, Honig G, Andrews L, Olinski LE, Mathur M, Oldach D. Humoral Response to COVID-19 Vaccines and Infection during Sibeprenlimab Treatment of IgA Nephropathy: Data from the ENVISION Trial. Clin J Am Soc Nephrol. 2026 Jun 11. doi: 10.2215/CJN.0000001089. Online ahead of print.
- Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sibeprenlimab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | Sibeprenlimab | Monoclonal antibody | 4 mg/kg | Intravenous |
| Subject | Sibeprenlimab | Monoclonal antibody | 8 mg/kg | Intravenous |