Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
120 participants
INTERVENTIONAL
2017-09-07
2021-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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)
Iguratimod
25mg twice a day, orally administrated
Steroids
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.
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)
Cyclophosphamide
1g/m², every 4 weeks, intravenous
Azathioprine
2mg/kg·d, once a day, orally administrated
Steroids
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.
Interventions
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Iguratimod
25mg twice a day, orally administrated
Cyclophosphamide
1g/m², every 4 weeks, intravenous
Azathioprine
2mg/kg·d, once a day, orally administrated
Steroids
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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RenJi Hospital
OTHER
Responsible Party
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Principal Investigators
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Chunde Bao, MD
Role: PRINCIPAL_INVESTIGATOR
RenJi Hospital
Locations
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RenJi Hospital
Shanghai, Shanghai Municipality, China
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Bao Chunde, MD
Role: primary
Jianping Tang, MD
Role: primary
References
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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.
Other Identifiers
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[2016]128k
Identifier Type: -
Identifier Source: org_study_id