drugset / Trial / NCT03214731
Efficacy and Safety of Artesunate Plus Standard of Care in Active Lupus Nephritis
Phase 4
Unknown
90 enrolled
Sun Yat-sen University
First Affiliated Hospital of Fujian Medical University · collabGeneral Hospital of Ningxia Medical University · collabShenzhen Second People's Hospital · collabThe First Affiliated Hospital of Nanchang University · collabThe First People's Hospital of Yunnan · collabThe Third Xiangya Hospital of Central South University · collabTongji Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a multi-center, randomized, double-blind, placebo-controlled study. Study subjects are class III, IV, V, III+V, IV+V lupus nephritis patients, according to ISN/RPS 2003 classification of LN, with active lesion needing corticosteroid in combination with immunosuppressant therapy. Subjects who meet the eligibility criteria during screening will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio: 25mg bid artesunate, 50mg bid artesunate or placebo plus standard of care (prednisone plus mycophenolate mofetil ［MMF］) for 6 month.
Timeline
- Start
- 2019-01-16
- Primary completion
- 2022-09-30
- Completion
- 2022-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Artesunate | Small molecule | 25 mg | — |
| Subject | Artesunate | Small molecule | 50 mg | — |