The Iguratimod Effect on Lupus Nephritis (IGeLU)

Lupus Nephritis Clinical Trial

— IGeLU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02936375
• Other study ID #: [2016]128k
• Status: Recruiting
• Phase: Phase 2
• Start date: September 7, 2017
• Est. completion date: November 2021

Study information

• Verified date: December 2018
• Source: RenJi Hospital
• Contact: Chunde Bao, MD
• Phone: 86-21-63284622
• Email: baochunde_1678[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 2021
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Active lupus nephritis:

• Fulfill ACR classification criteria (2009) for SLE

• Proteinuria =1g/24h at screening

• Nephritis of class III, IV, V, III+IV or IV+V, confirmed by renal pathology within 90 days prior to screening

• Body weight =40kg

• SLE-2K score =8

• Agreement of contraception

• Informed consent obtained

Exclusion Criteria:

• Active severe SLE-driven renal disease or unstable renal disease at screening

• Active severe or unstable neuropsychiatric SLE

• Clinically significant active infection including ongoing and chronic infections

• History of receiving cyclophosphamide, azathioprine, tacrolimus , mycophenolate moetil or rituximab treatment with 90 days prior to screening

• History of human immunodeficiency virus (HIV)

• Confirmed Positive tests for hepatitis B or positive test for hepatitis C

• Active tuberculosis

• Live or attenuated vaccine within 4 weeks prior to screening

• Subjects with significant hematologic abnormalities

• Abnormal liver function test at screening (ALT, AST or total bilirubin over 2 fold of upper normal level

• History of peptic ulcer or GI bleeding; treatment with warfarin or other anticoagulants within last 14 days

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• Iguratimod
25mg twice a day, orally administrated
• Cyclophosphamide
1g/m², every 4 weeks, intravenous
• Azathioprine
2mg/kg·d, once a day, orally administrated
• 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.

Locations

Country	Name	City	State
China	RenJi Hospital	Shanghai	Shanghai
China	Shanghai Tongji Hospital, Tongji University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renal remission rate		Week 52
Secondary	Renal remission rate		Week 24
Secondary	Renal flare rate		Week 52
Secondary	Number of participants with treatment-related adverse events	adverse events are assessed by CTCAE v4.0	Week 52
Secondary	SLEDAI-2K score	SLE SLE disease activity index (2000)	Week 52
Secondary	BILAG score	British Isles lupus assessment group score	Week 52
Secondary	PGA	Patient general assessment	Week