The Iguratimod Effect on Lupus Nephritis (IGeLU)

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 2

Conditions: Lupus Nephritis

Treatments: Drug: Azathioprine; Drug: Iguratimod; Drug: Steroids; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT02936375

[2016]128k

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Iguratimod

Experimental group

Description:

Patients will receive iguratimod over the whole follow-up, combined with steroids, as well as auxiliary treatment (such as vitamin D, gastrointestinal agents, blood pressure medications, if any)

Treatment:

Drug: Steroids

Drug: Iguratimod

Cyc+AZA

Active Comparator group

Description:

Patients will receive cyclophosphamide in the first half of study (usually to 24 weeks), followed with azathioprine till the end of follow-up. Patients will also receive steroids as combinational therapy, as well as auxiliary treatment (such as vitamin D, gastrointestinal agents, blood pressure medications, if any)

Treatment:

Drug: Steroids

Drug: Azathioprine

Drug: Cyclophosphamide