Iguratimod as Treatment for Refractory Lupus Nephritis

February 23, 2017 updated by: RenJi Hospital

Evaluation of Clinical Efficacy and Immunologic Response After Iguratimod Therapy in Refractory Lupus Nephritis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200001
        • Renji Hospital

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 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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

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
Systemic Lupus Erythematosus Disease Activity Index inSafety of Estrogens in Lupus Erythematosus National Assessment (SELENA-SLEDAI)
Time Frame: Week 52
Week 52
British Isles Lupus Activity Group (BILAG) score
Time Frame: Week 52
Week 52
PGA
Time Frame: Week 52
Patient general assessment
Week 52
Quality of life
Time Frame: Week 52
Measured by HAQ
Week 52

Collaborators and Investigators

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

Sponsor

RenJi Hospital

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 (Anticipated)

May 8, 2017

Primary Completion (Anticipated)

May 8, 2018

Study Completion (Anticipated)

April 30, 2019

Study Registration Dates

First Submitted

February 11, 2017

First Submitted That Met QC Criteria

February 11, 2017

First Posted (Actual)

February 15, 2017

Study Record Updates

Last Update Posted (Actual)

February 27, 2017

Last Update Submitted That Met QC Criteria

February 23, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [2017]27

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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