Iguratimod as Treatment for Refractory Lupus Nephritis

NCT ID: NCT03054545

Last Updated: 2017-02-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-08
• Study Completion Date: 2019-04-30

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.

Conditions

Lupus Nephritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Iguratimod treating group

Iguratimod 25mg twice a day, oral administrated.

Group Type: EXPERIMENTAL

Iguratimod

Intervention Type: DRUG

Iguratimod 25mg twice a day, oral administrated.

Interventions

Iguratimod

Iguratimod 25mg twice a day, oral administrated.

Intervention Type: DRUG

Other Intervention Names

T-614

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

RenJi Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

[2017]27

Identifier Type: -

Identifier Source: org_study_id