Iguratimod as Treatment for Refractory Lupus Nephritis

Shanghai Jiao Tong University

Status

Unknown

Conditions

Lupus Nephritis

Treatments

Drug: Iguratimod

Study type

Interventional

Funder types

Other

Identifiers

NCT03054545

[2017]27

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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