drugset / Trial / NCT05627557
A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome
RandomizedParallel-groupOpen-labelTreatment
Summary
This open-label, randomized multicenter study is to assess the efficacy, safety, and pharmacokinetics (PK)/pharmacodynamics (PD) of obinutuzumab compared with mycophenolate mofetil (MMF) in children and young adults (aged \>= 2-25 years) with frequently relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS).
Timeline
- Start
- 2023-03-29
- Primary completion
- 2025-09-04
- Completion
- 2026-09-04
Publications
- Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6.
- Dossier C, Bonneric S, Baudouin V, Kwon T, Prim B, Cambier A, Couderc A, Moreau C, Deschenes G, Hogan J. Obinutuzumab in Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome in Children. Clin J Am Soc Nephrol. 2023 Dec 1;18(12):1555-1562. doi: 10.2215/CJN.0000000000000288. Epub 2023 Sep 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Mycophenolate Mofetil | Small molecule | 600 mg/m2 | Oral |
| Subject | Obinutuzumab | Monoclonal antibody | 20 mg/kg | Intravenous |
| Subject | Obinutuzumab | Monoclonal antibody | 1000 mg | Intravenous |
| Background | Acetaminophen | Small molecule | 15 mg/kg | Oral |
| Background | Diphenhydramine | Unknown | 0.5 mg/kg | Oral |
| Background | Diphenhydramine | Unknown | 1 mg/kg | Oral |
| Background | Methylprednisolone | Other / unclassified | 1.5 mg/kg | Intravenous |
| Background | Methylprednisolone | Other / unclassified | 80 mg | Intravenous |
| Background | Prednisone | Other / unclassified | — | — |