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Efficacy and Safety of Artesunate Plus Standard of Care in Active Lupus Nephritis

NCT03214731 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-09-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Artesunate

Artesunate was produced by pharmaceutical factory for research specifically

OTHER

placebo

placebo was produced by pharmaceutical factory for research specifically

Sponsors & Collaborators

  • The First People's Hospital of Yunnan

    collaborator OTHER

  • The First Affiliated Hospital of Nanchang University

    collaborator OTHER

  • General Hospital of Ningxia Medical University

    collaborator OTHER

  • First Affiliated Hospital of Fujian Medical University

    collaborator OTHER

  • Shenzhen Second People's Hospital

    collaborator OTHER

  • The Third Xiangya Hospital of Central South University

    collaborator OTHER

  • Tongji Hospital

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-16
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03214731 on ClinicalTrials.gov