NCT02936375

The Iguratimod Effect on Lupus Nephritis (IGeLU)

The Effect of Iguratimod on Active Lupus Nephritis, the IGeLU Study: a Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

• Lupus Nephritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-09-07
• Primary completion: 2020-11-01
• Completion: 2021-11-01
• First posted: 2016-10-18
• Last updated: 2018-12-19

Locations

2 sites across 1 country: China