The Iguratimod Effect on Lupus Nephritis (IGeLU)

NCT02936375 | Unknown Phase 2

• 1 other identifier: [2016]128k
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

lupus; nephritis; iguratimod

Outcome Measures

Primary Outcomes (1)

• renal remission rate

  Week 52

Secondary Outcomes (6)

• Renal remission rate

  Week 24

• Renal flare rate

  Week 52

• Number of participants with treatment-related adverse events

  Week 52

• SLEDAI-2K score

  Week 52

• BILAG score

  Week 52

Study Arms (2)

Iguratimod

EXPERIMENTAL

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)

Drug: Iguratimod; Drug: Steroids

Cyc+AZA

ACTIVE COMPARATOR

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)

Drug: Cyclophosphamide; Drug: Azathioprine; Drug: Steroids

Interventions

Iguratimod DRUG

25mg twice a day, orally administrated

Also known as: T-614 (code name), Iremod (brand name)

Iguratimod

Cyclophosphamide DRUG

1g/m², every 4 weeks, intravenous

Cyc+AZA

Azathioprine DRUG

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

Cyc+AZA

Steroids DRUG

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.

Cyc+AZA; Iguratimod

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (2)

RenJi Hospital

Shanghai, Shanghai Municipality, 200001, China

RECRUITING

Shanghai Tongji Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, 200065, China

RECRUITING

Related Publications (1)

• Yan Q, Du F, Kang Y, Ye P, Wang X, Xu J, Tang J, Wang N, Jiang G, Li Z, Wang X, Xue Q, Huang X, Zhang X, Zhou Y, Dai M, Bao C. Comparison of iguratimod and conventional cyclophosphamide with sequential azathioprine as treatment of active lupus nephritis: study protocol for a multi-center, randomized, controlled clinical trial (iGeLU study). Trials. 2021 Aug 11;22(1):530. doi: 10.1186/s13063-021-05475-3.

  PMID: 34380536 DERIVED

MeSH Terms

Conditions

Lupus Nephritis; Nephritis

Interventions

iguratimod; T 614; Clinical Coding; Cyclophosphamide; Azathioprine; Steroids

Condition Hierarchy (Ancestors)

Glomerulonephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Forms and Records Control; Office Management; Practice Management; Professional Practice; Organization and Administration; Health Services Administration; Medical Records; Records; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Methods; Public Health; Environment and Public Health; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Thionucleosides; Sulfur Compounds; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Chunde Bao, MD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunde Bao, MD

CONTACT

86-21-63284622; baochunde_1678@126.com

Qingran Yan, MD

CONTACT

86-21-53882280; YanQingran@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 18, 2016
• Study Start: September 7, 2017
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2021
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

CN (2)