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Iguratimod as Treatment for Refractory Lupus Nephritis

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ClinicalTrials.gov Identifier: NCT03054545
Recruitment Status : Not yet recruiting
First Posted : February 15, 2017
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

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
Lupus Nephritis Drug: Iguratimod Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Estimated Study Start Date : May 8, 2017
Estimated Primary Completion Date : May 8, 2018
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Iguratimod treating group
Iguratimod 25mg twice a day, oral administrated.
Drug: Iguratimod
Iguratimod 25mg twice a day, oral administrated.
Other Name: T-614




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. Systemic Lupus Erythematosus Disease Activity Index inSafety of Estrogens in Lupus Erythematosus National Assessment (SELENA-SLEDAI) [ Time Frame: Week 52 ]
  5. British Isles Lupus Activity Group (BILAG) score [ Time Frame: Week 52 ]
  6. PGA [ Time Frame: Week 52 ]
    Patient general assessment

  7. Quality of life [ Time Frame: Week 52 ]
    Measured by HAQ



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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 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

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): NCT03054545


Locations
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China, Shanghai
RenJi Hospital
Shanghai, Shanghai, China, 200001
Sponsors and Collaborators
RenJi Hospital

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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT03054545     History of Changes
Other Study ID Numbers: [2017]27
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017

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

Additional relevant MeSH terms:
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Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases