Iguratimod as Treatment for Refractory Lupus Nephritis

NCT03054545 | Unknown

• 1 other identifier: [2017]27
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Renal remission rate

  Week 52

Secondary Outcomes (7)

• Renal remission rate

  Week 24

• Renal flare rate

  Week 52

• Number of participants with treatment-related adverse events

  Week 52

• Systemic Lupus Erythematosus Disease Activity Index inSafety of Estrogens in Lupus Erythematosus National Assessment (SELENA-SLEDAI)

  Week 52

• British Isles Lupus Activity Group (BILAG) score

  Week 52

Study Arms (1)

Iguratimod treating group

EXPERIMENTAL

Iguratimod 25mg twice a day, oral administrated.

Drug: Iguratimod

Interventions

Iguratimod DRUG

Iguratimod 25mg twice a day, oral administrated.

Also known as: T-614

Iguratimod treating group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

RenJi Hospital

Shanghai, Shanghai Municipality, 200001, China

Location

MeSH Terms

Conditions

Lupus Nephritis

Interventions

iguratimod; T 614

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2017
• First Posted: February 15, 2017
• Study Start: May 8, 2017
• Primary Completion: May 8, 2018
• Study Completion: April 30, 2019
• Last Updated: February 27, 2017

Record last verified: 2017-02

Locations

CN (1)