The Iguratimod Effect on Lupus Nephritis (IGeLU) (IGeLU)

December 18, 2018 updated by: RenJi Hospital

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

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200001
        • Recruiting
        • Renji Hospital
        • Contact:
        • Principal Investigator:
          • Bao Chunde, MD
        • Sub-Investigator:
          • Qingran Yan, MD
      • Shanghai, Shanghai, China, 200065
        • Recruiting
        • Shanghai Tongji Hospital, Tongji University School of Medicine
        • Contact:
        • Principal Investigator:
          • Jianping Tang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iguratimod
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)
25mg twice a day, orally administrated
Other Names:
  • T-614 (code name)
  • Iremod (brand name)
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.
Active Comparator: Cyc+AZA
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)
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.
1g/m², every 4 weeks, intravenous
2mg/kg·d, once a day, orally administrated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
renal remission rate
Time Frame: Week 52
Week 52

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Chunde Bao, MD, Renji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2017

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

October 12, 2016

First Submitted That Met QC Criteria

October 16, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 18, 2018

Last Verified

December 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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