drugset / Trial / NCT02936375

The Iguratimod Effect on Lupus Nephritis (IGeLU)

NCT02936375

Phase 2 Unknown 120 enrolled RenJi Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Azathioprine Small molecule 2 mg/kg Oral
Comparator Cyclophosphamide Other / unclassified 1 g Intravenous
Subject Iguratimod Small molecule 25 mg Oral
Background Methylprednisolone Other / unclassified 10 mg Oral
Background Prednisone Other / unclassified 10 mg Oral
Background prednisonlone Unknown 10 mg Oral

Indications