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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iguratimod | Experimental | 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) |
|
| Cyc+AZA | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iguratimod | Drug | 25mg twice a day, orally administrated |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| renal remission rate | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Renal remission rate | Week 24 | |
| Renal flare rate | Week 52 | |
| Number of participants with treatment-related adverse events |
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Inclusion Criteria:
Active lupus nephritis:
Body weight ≥40kg
SLE-2K score ≥8
Agreement of contraception
Informed consent obtained
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunde Bao, MD | Contact | 86-21-63284622 | baochunde_1678@126.com | |
| Qingran Yan, MD | Contact | 86-21-53882280 | YanQingran@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chunde Bao, MD | RenJi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RenJi Hospital | Recruiting | Shanghai | Shanghai Municipality | 200001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34380536 | Derived | Yan Q, Du F, Kang Y, Ye P, Wang X, Xu J, Tang J, Wang N, Jiang G, Li Z, Wang X, Xue Q, Huang X, Zhang X, Zhou Y, Dai M, Bao C. Comparison of iguratimod and conventional cyclophosphamide with sequential azathioprine as treatment of active lupus nephritis: study protocol for a multi-center, randomized, controlled clinical trial (iGeLU study). Trials. 2021 Aug 11;22(1):530. doi: 10.1186/s13063-021-05475-3. |
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| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| D009393 | Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C519076 | iguratimod |
| C077313 | T 614 |
| D059019 | Clinical Coding |
| D003520 | Cyclophosphamide |
| D001379 | Azathioprine |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D005568 | Forms and Records Control |
| D009817 | Office Management |
| D020399 | Practice Management |
| D011364 | Professional Practice |
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| Cyclophosphamide | Drug | 1g/m², every 4 weeks, intravenous |
|
| Azathioprine | Drug | 2mg/kg·d, once a day, orally administrated |
|
| Steroids | Drug | 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. |
|
adverse events are assessed by CTCAE v4.0 |
| Week 52 |
| SLEDAI-2K score | SLE SLE disease activity index (2000) | Week 52 |
| BILAG score | British Isles lupus assessment group score | Week 52 |
| PGA | Patient general assessment | Week |
| Shanghai Tongji Hospital, Tongji University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200065 | China |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009934 |
| Organization and Administration |
| D006298 | Health Services Administration |
| D008499 | Medical Records |
| D011996 | Records |
| D003625 | Data Collection |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D004812 | Epidemiologic Methods |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D015122 | Mercaptopurine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |