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Trial record 11 of 698 for:    lupus

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

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ClinicalTrials.gov Identifier: NCT02936375
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

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.

Condition or disease Intervention/treatment Phase
Lupus Nephritis Drug: Iguratimod Drug: Cyclophosphamide Drug: Azathioprine Drug: Steroids Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Iguratimod on Active Lupus Nephritis, the IGeLU Study: a Randomized Controlled Trial
Actual Study Start Date : September 7, 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


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)
Drug: Iguratimod
25mg twice a day, orally administrated
Other Names:
  • T-614 (code name)
  • Iremod (brand name)

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.

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)
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.




Primary Outcome Measures :
  1. renal remission rate [ Time Frame: Week 52 ]

Secondary Outcome Measures :
  1. Renal remission rate [ Time Frame: Week 24 ]
  2. Renal flare rate [ Time Frame: Week 52 ]
  3. Number of participants with treatment-related adverse events [ Time Frame: Week 52 ]
    adverse events are assessed by CTCAE v4.0

  4. SLEDAI-2K score [ Time Frame: Week 52 ]
    SLE SLE disease activity index (2000)

  5. BILAG score [ Time Frame: Week 52 ]
    British Isles lupus assessment group score

  6. PGA [ Time Frame: Week ]
    Patient general assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02936375


Contacts
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Contact: Chunde Bao, MD 86-21-63284622 baochunde_1678@126.com
Contact: Qingran Yan, MD 86-21-53882280 YanQingran@163.com

Locations
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China, Shanghai
RenJi Hospital Recruiting
Shanghai, Shanghai, China, 200001
Contact: Bao Chunde, MD    021-63284622    baochunde_1678@yahoo.com.cn   
Principal Investigator: Bao Chunde, MD         
Sub-Investigator: Qingran Yan, MD         
Shanghai Tongji Hospital, Tongji University School of Medicine Recruiting
Shanghai, Shanghai, China, 200065
Contact: Jianping Tang, MD    86-21-56051080    tangjp6512@126.com   
Principal Investigator: Jianping Tang, MD         
Sponsors and Collaborators
RenJi Hospital
Investigators
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Principal Investigator: Chunde Bao, MD RenJi Hospital

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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT02936375     History of Changes
Other Study ID Numbers: [2016]128k
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by RenJi Hospital:
lupus
nephritis
iguratimod

Additional relevant MeSH terms:
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Lupus Nephritis
Lupus Erythematosus, Systemic
Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Cyclophosphamide
Azathioprine
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites
Antimetabolites, Antineoplastic