drugset / Trial / NCT05532111
Efficacy and Safety of the Treatment of Primary Membranous Nephropathy: A Randomized Clinical Trial
RandomizedParallel-groupOpen-labelTreatment
Summary
1. Main purpose: To evaluate the efficacy and safety of rituximab combined with tacrolimus in the treatment of intermediate and high-risk primary membranous nephropathy 2. Secondary research purposes: To describe the survival of patients with intermediate and high-risk primary membranous nephropathy treated with rituximab combined with tacrolimus; To describe renal survival in patients with intermediate and high-risk primary membranous nephropathy treated with rituximab combined with tacrolimus; 3. Exploratory research purposes: Feasibility of glucocorticoids-free therapy (rituximab combined with tacrolimus) in the treatment of intermediate and high-risk primary membranous nephropathy
Timeline
- Start
- 2022-09-01
- Primary completion
- 2023-09-30
- Completion
- 2024-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Subject | Prednisolone | Other / unclassified | 0.5 mg/kg | — |
| Subject | Prednisolone | Other / unclassified | 1 mg/kg | — |
| Subject | Prednisone | Other / unclassified | 0.5 mg/kg | — |
| Subject | Prednisone | Other / unclassified | 1 mg/kg | — |
| Subject | Rituximab | Monoclonal antibody | 1 g | — |
| Subject | Tacrolimus | Small molecule | 0.05 mg/kg | Oral |
| Subject | Tacrolimus | Small molecule | 0.1 mg/kg | Oral |
Indications
No indication recorded.