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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03054545
Other study ID # [2017]27
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 11, 2017
Last updated February 23, 2017
Start date May 8, 2017
Est. completion date April 30, 2019

Study information

Verified date February 2017
Source RenJi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date April 30, 2019
Est. primary completion date May 8, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Iguratimod
Iguratimod 25mg twice a day, oral administrated.

Locations

Country Name City State
China RenJi Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Renal remission rate Week 52
Secondary Renal remission rate Week 24
Secondary Renal flare rate Week 52
Secondary Number of participants with treatment-related adverse events Adverse events are assessed by CTCAE v4.0 Week 52
Secondary Systemic Lupus Erythematosus Disease Activity Index inSafety of Estrogens in Lupus Erythematosus National Assessment (SELENA-SLEDAI) Week 52
Secondary British Isles Lupus Activity Group (BILAG) score Week 52
Secondary PGA Patient general assessment Week 52
Secondary Quality of life Measured by HAQ Week 52
See also
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