- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02936375
The Iguratimod Effect on Lupus Nephritis (IGeLU) (IGeLU)
December 18, 2018 updated by: RenJi Hospital
The Effect of Iguratimod on Active Lupus Nephritis, the IGeLU Study: a Randomized Controlled Trial
This study is a 52-week, randomized, open, active-controlled trial of patients with active diffused lupus nephritis, to assess the efficacy and safety of a novel chemical synthetic agent iguratimod.
The subjects will randomly receive iguratimod or cyclophosphamide followed with azathioprine, both combined with steroids.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chunde Bao, MD
- Phone Number: 86-21-63284622
- Email: baochunde_1678@126.com
Study Contact Backup
- Name: Qingran Yan, MD
- Phone Number: 86-21-53882280
- Email: YanQingran@163.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200001
- Recruiting
- Renji Hospital
-
Contact:
- Bao Chunde, MD
- Phone Number: 021-63284622
- Email: baochunde_1678@yahoo.com.cn
-
Principal Investigator:
- Bao Chunde, MD
-
Sub-Investigator:
- Qingran Yan, MD
-
Shanghai, Shanghai, China, 200065
- Recruiting
- Shanghai Tongji Hospital, Tongji University School of Medicine
-
Contact:
- Jianping Tang, MD
- Phone Number: 86-21-56051080
- Email: tangjp6512@126.com
-
Principal Investigator:
- Jianping Tang, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Active lupus nephritis:
- Fulfill ACR classification criteria (2009) for SLE
- Proteinuria ≥1g/24h at screening
- Nephritis of class III, IV, V, III+IV or IV+V, confirmed by renal pathology within 90 days prior to screening
- 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 receiving cyclophosphamide, azathioprine, tacrolimus , mycophenolate moetil or rituximab treatment with 90 days prior to screening
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Iguratimod
Patients will receive iguratimod over the whole follow-up, combined with steroids, as well as auxiliary treatment (such as vitamin D, gastrointestinal agents, blood pressure medications, if any)
|
25mg twice a day, orally administrated
Other Names:
Prednisone, methylprednisolone or prednisonlone, once a day, orally administrated.
Steroids should be 1mg/kg·d in the beginning four weeks, then tapered 5-10mg/d every two weeks till 30mg/d, then tapered 2.5-5mg/d every two weeks.
After 24 weeks of follow-up, a patient should receive steroids no more than 10mg/d.
Patients may receive temporal high dose of steroids (1mg/kg·d) because of symptoms outside of kidney, for no more than two weeks.
All the dosage of steroids above is calculated by prednisone.
|
Active Comparator: Cyc+AZA
Patients will receive cyclophosphamide in the first half of study (usually to 24 weeks), followed with azathioprine till the end of follow-up.
Patients will also receive steroids as combinational therapy, as well as auxiliary treatment (such as vitamin D, gastrointestinal agents, blood pressure medications, if any)
|
Prednisone, methylprednisolone or prednisonlone, once a day, orally administrated.
Steroids should be 1mg/kg·d in the beginning four weeks, then tapered 5-10mg/d every two weeks till 30mg/d, then tapered 2.5-5mg/d every two weeks.
After 24 weeks of follow-up, a patient should receive steroids no more than 10mg/d.
Patients may receive temporal high dose of steroids (1mg/kg·d) because of symptoms outside of kidney, for no more than two weeks.
All the dosage of steroids above is calculated by prednisone.
1g/m², every 4 weeks, intravenous
2mg/kg·d, once a day, orally administrated
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
renal remission rate
Time Frame: Week 52
|
Week 52
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Renal remission rate
Time Frame: Week 24
|
Week 24
|
|
Renal flare rate
Time Frame: Week 52
|
Week 52
|
|
Number of participants with treatment-related adverse events
Time Frame: Week 52
|
adverse events are assessed by CTCAE v4.0
|
Week 52
|
SLEDAI-2K score
Time Frame: Week 52
|
SLE SLE disease activity index (2000)
|
Week 52
|
BILAG score
Time Frame: Week 52
|
British Isles lupus assessment group score
|
Week 52
|
PGA
Time Frame: Week
|
Patient general assessment
|
Week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chunde Bao, MD, Renji Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 7, 2017
Primary Completion (Anticipated)
November 1, 2020
Study Completion (Anticipated)
November 1, 2021
Study Registration Dates
First Submitted
October 12, 2016
First Submitted That Met QC Criteria
October 16, 2016
First Posted (Estimate)
October 18, 2016
Study Record Updates
Last Update Posted (Actual)
December 19, 2018
Last Update Submitted That Met QC Criteria
December 18, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Kidney Diseases
- Urologic Diseases
- Connective Tissue Diseases
- Glomerulonephritis
- Lupus Erythematosus, Systemic
- Nephritis
- Lupus Nephritis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Cyclophosphamide
- Azathioprine
Other Study ID Numbers
- [2016]128k
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lupus Nephritis
-
Imperial College LondonKarolinska Institutet; Ohio State University; Dutch Working Party on Systemic... and other collaboratorsTerminatedSystemic Lupus Erythematosus, Lupus NephritisUnited Kingdom
-
Sun Yat-sen UniversityCompleted
-
Peking UniversityCompleted
-
University Hospital, GrenobleInstitut de Biologie Structurale GrenobleCompletedSystemic Lupus Erythematosus NephritisFrance
-
Peking Union Medical College HospitalUnknownNephritis, LupusChina
-
Artiva Biotherapeutics, Inc.RecruitingLupus Nephritis - WHO Class IV | Lupus Nephritis - WHO Class IIIUnited States
-
Minia UniversityNot yet recruitingmfERG in Lupus NephritisEgypt
-
Kyverna TherapeuticsRecruitingLupus Nephritis | Lupus Nephritis - World Health Organization (WHO) Class III | Lupus Nephritis - WHO Class IVUnited States
-
Centre Hospitalier Universitaire, AmiensCompletedLupus Nephritis | Systemic Lupus Erythematosus (SLE)France
-
La Jolla Pharmaceutical CompanyCompletedAutoimmune Diseases | Systemic Lupus Erythematosus | Lupus Nephritis | Immunologic Diseases | Lupus GlomerulonephritisUnited States, Austria, Canada, France, Germany, Italy, Mexico, Spain, Sweden, United Kingdom
Clinical Trials on Iguratimod
-
Jiangsu Simcere Pharmaceutical Co., Ltd.UnknownRheumatoid ArthritisChina
-
Jiangsu Simcere Pharmaceutical Co., Ltd.Completed
-
Jiangsu Simcere Pharmaceutical Co., Ltd.Recruiting
-
Xuzhou Medical UniversityRecruiting
-
Eisai Co., Ltd.CompletedRheumatoid ArthritisJapan
-
Peking University People's HospitalNot yet recruitingHand Osteoarthritis | Inflammatory Arthritis
-
Peking Union Medical College HospitalUnknown
-
Peking University People's HospitalNot yet recruitingImmune ThrombocytopeniaChina