Iguratimod as Treatment for Refractory Lupus Nephritis

Lupus Nephritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03054545
• Other study ID #: [2017]27
• 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
• 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

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

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