Back to resultsIguratimod as Treatment for Refractory Lupus Nephritis
Primary Purpose
Lupus Nephritis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Iguratimod
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Nephritis
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
Sites / Locations
- RenJi Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Iguratimod treating group
Arm Description
Iguratimod 25mg twice a day, oral administrated.
Outcomes
Primary Outcome Measures
Renal remission rate
Secondary Outcome Measures
Renal remission rate
Renal flare rate
Number of participants with treatment-related adverse events
Adverse events are assessed by CTCAE v4.0
Systemic Lupus Erythematosus Disease Activity Index inSafety of Estrogens in Lupus Erythematosus National Assessment (SELENA-SLEDAI)
British Isles Lupus Activity Group (BILAG) score
PGA
Patient general assessment
Quality of life
Measured by HAQ
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03054545
Brief Title
Iguratimod as Treatment for Refractory Lupus Nephritis
Official Title
Evaluation of Clinical Efficacy and Immunologic Response After Iguratimod Therapy in Refractory Lupus Nephritis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 8, 2017 (Anticipated)
Primary Completion Date
May 8, 2018 (Anticipated)
Study Completion Date
April 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Iguratimod treating group
Arm Type
Experimental
Arm Description
Iguratimod 25mg twice a day, oral administrated.
Intervention Type
Drug
Intervention Name(s)
Iguratimod
Other Intervention Name(s)
T-614
Intervention Description
Iguratimod 25mg twice a day, oral administrated.
Primary Outcome Measure Information:
Title
Renal remission rate
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Renal remission rate
Time Frame
Week 24
Title
Renal flare rate
Time Frame
Week 52
Title
Number of participants with treatment-related adverse events
Description
Adverse events are assessed by CTCAE v4.0
Time Frame
Week 52
Title
Systemic Lupus Erythematosus Disease Activity Index inSafety of Estrogens in Lupus Erythematosus National Assessment (SELENA-SLEDAI)
Time Frame
Week 52
Title
British Isles Lupus Activity Group (BILAG) score
Time Frame
Week 52
Title
PGA
Description
Patient general assessment
Time Frame
Week 52
Title
Quality of life
Description
Measured by HAQ
Time Frame
Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
RenJi Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200001
Country
China
12. IPD Sharing Statement
Learn more about this trial
Iguratimod as Treatment for Refractory Lupus Nephritis
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