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Iguratimod as Treatment for Refractory Lupus Nephritis

Sponsor
RenJi Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03054545
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
23.7
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to evaluate the efficacy and safety of a novel chemical synthetic agent iguratimod as treatment of refractory lupus nephritis. All subjects should have at least one failed immunosuppressive treatment and suffer active nephritis at the screening stage. The study period is 52 week. All the subject will receive therapy of iguratimod combined with steroids.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Clinical Efficacy and Immunologic Response After Iguratimod Therapy in Refractory Lupus Nephritis
Anticipated Study Start Date :
May 8, 2017
Anticipated Primary Completion Date :
May 8, 2018
Anticipated Study Completion Date :
Apr 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Iguratimod treating group

Iguratimod 25mg twice a day, oral administrated.

Drug: Iguratimod
Iguratimod 25mg twice a day, oral administrated.
Other Names:
  • T-614

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Renal remission rate [Week 52]

    Secondary Outcome Measures

    1. Renal remission rate [Week 24]

    2. Renal flare rate [Week 52]

    3. Number of participants with treatment-related adverse events [Week 52]

      Adverse events are assessed by CTCAE v4.0

    4. Systemic Lupus Erythematosus Disease Activity Index inSafety of Estrogens in Lupus Erythematosus National Assessment (SELENA-SLEDAI) [Week 52]

    5. British Isles Lupus Activity Group (BILAG) score [Week 52]

    6. PGA [Week 52]

      Patient general assessment

    7. Quality of life [Week 52]

      Measured by HAQ

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Active lupus nephritis:

    Fulfill ACR classification criteria (2009) for SLE Proteinuria ≥1g/24h at screening stage experience at least one failed therapy within one year before screening, including but not limit to cyclophosphamide, methotrexate, azathioprine, mycophenolate mofetil, cyclosporin, tacrolimus and leflunomide. The regime can be monotherapy or combination. Any regime should be at least applied for six months.

    • 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 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 RenJi Hospital Shanghai Shanghai China 200001

    Sponsors and Collaborators

    • RenJi Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT03054545
    Other Study ID Numbers:
    • [2017]27
    First Posted:
    Feb 15, 2017
    Last Update Posted:
    Feb 27, 2017
    Last Verified:
    Feb 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Nephritis
    Lupus Nephritis

    Study Results

    No Results Posted as of Feb 27, 2017