Efficacy and Safety of Artesunate Plus Standard of Care in Active Lupus Nephritis
Status:
Recruiting
Trial end date:
2022-09-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Sun Yat-sen University
Collaborators:
First Affiliated Hospital of Fujian Medical University General Hospital of Ningxia Medical University Shenzhen Second People's Hospital The First Affiliated Hospital of Nanchang University The First People's Hospital of Yunnan The Third Xiangya Hospital of Central South University Tongji Hospital