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The Iguratimod Effect on Lupus Nephritis (IGeLU)

NCT02936375 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-12-19

No results posted yet for this study

Summary

This study is a 52-week, randomized, open, active-controlled trial of patients with active diffused lupus nephritis, to assess the efficacy and safety of a novel chemical synthetic agent iguratimod. The subjects will randomly receive iguratimod or cyclophosphamide followed with azathioprine, both combined with steroids.

Conditions

Interventions

DRUG

Iguratimod

25mg twice a day, orally administrated

DRUG

Cyclophosphamide

1g/m², every 4 weeks, intravenous

DRUG

Azathioprine

2mg/kg·d, once a day, orally administrated

DRUG

Steroids

Prednisone, methylprednisolone or prednisonlone, once a day, orally administrated. Steroids should be 1mg/kg·d in the beginning four weeks, then tapered 5-10mg/d every two weeks till 30mg/d, then tapered 2.5-5mg/d every two weeks. After 24 weeks of follow-up, a patient should receive steroids no more than 10mg/d. Patients may receive temporal high dose of steroids (1mg/kg·d) because of symptoms outside of kidney, for no more than two weeks. All the dosage of steroids above is calculated by prednisone.

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Chunde Bao, MD · RenJi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-09-07
Primary Completion
2020-11-30
Completion
2021-11-30

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT02936375 on ClinicalTrials.gov