Assess the Efficacy and Safety of Multi-target Therapy in Lupus Nephritis
NCT ID: NCT00876616
Last Updated: 2013-08-29
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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COMPLETED
NA
362 participants
INTERVENTIONAL
2009-04-30
2012-02-29
Brief Summary
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Detailed Description
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2. To investigate the safety and tolerability of FK506 combined with MMF vs intravenous CTX pulses in the treatment of class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+Ⅴ LN.
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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Tacrolimus+Mycophenolate mofetil
FK506 4mg/d+MMF 1.0g/d
Tacrolimus+Mycophenolate mofetil
FK506 4mg/d,MMF 1.0g/d
Cyclophosphamide
CTX iv 0.75 g/m2 body surface area (BSA)
Cyclophosphamide
CTX 0.75g/m2 BSA
Interventions
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Tacrolimus+Mycophenolate mofetil
FK506 4mg/d,MMF 1.0g/d
Cyclophosphamide
CTX 0.75g/m2 BSA
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 18 to 65 years of age (inclusive 18 and 65), male or female
3. Diagnosis of SLE according to the American College of Rheumatology criteria (1997)
4. Diagnosis of Class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+ⅤLN according to the ISN/RPS 2003 classification by light, immunofluorescence, and electron microscopy within 6 months before enrollment
5. Pathologic chronic index (CI) ≤3' without thrombotic microangiopathy (TMA)
6. SLE Disease Activity Index (DAI) \>10'
7. Proteinuria ≥1.5g/d，with or without active urinary sediment
8. Serum creatinine (Scr)≤3.0mg/dl (265.2 mol/L)
Exclusion Criteria
2. ALT or AST increase twice above the upper limit of the normal range
3. Hyperglycemia is defined as fasting blood glucose level ≥7.0 mmol/L and/or postprandial blood sugar level\>11.1 mmol/L
4. Known hypersensitivity or contraindication to any components of MMF, tacrolimus, CTX or glucocorticoids
5. History of present illness:
1. active HBV infection (HBsAg, HBeAg and anti-HBc positive or HBsAg, anti- HBe and anti-HBc positive), HCV infection, pulmonary tuberculosis, cytomegalovirus(CMV) infection (defined as CMV-IgM positive or CMV-DNA positive), fungal infection or HIV infection, within 3 months before the enrollment
2. non-healed active peptic ulcer within 3 months before the enrollment
3. drug or drinking abuse
4. malnutrition (BMI \<18.5kg/m2) or body weight \<50Kg
6. Other active diseases, such as:
1. severe cardiovascular diseases
2. chronic obstructive pulmonary disease(COPD)or asthma requiring oral glucocorticoids
3. marrow depression not due to SLE activation: white blood cell count \<3000/mm3 or neutrophil count \<1300/mm3 or platelet count \<50000/mm3
7. Severe infection or need of antibiotic therapy
8. Female patients who are pregnant/breastfeeding or those patients (both gender) who refused contraception
9. Life-threatening complications such as large hydropericardium, pneumohemorrhagia, lupus encephalopathy and severe pulmonary hypertension or patients in need of MP pulse (\>0.5g/d ) treatment because of aggravation of SLE
10. Known to be non-compliance or violation of the protocol base on investigator's judgement
11. Patient who participate of any other investigational drug study.
18 Years
65 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
West China Hospital
OTHER
RenJi Hospital
OTHER
China Medical University, China
OTHER
Huashan Hospital
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Beijing Friendship Hospital
OTHER
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Zhi-Hong Liu, M.D.
OTHER
Responsible Party
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Zhi-Hong Liu, M.D.
professor
Principal Investigators
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Zhihong Liu, Master
Role: PRINCIPAL_INVESTIGATOR
Nanjing University School of Medicine
Locations
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Research Institute of Nephrology,Jinling Hospital
Nanjing, Jiangsu, China
Countries
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References
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Liu Z, Zhang H, Liu Z, Xing C, Fu P, Ni Z, Chen J, Lin H, Liu F, He Y, He Y, Miao L, Chen N, Li Y, Gu Y, Shi W, Hu W, Liu Z, Bao H, Zeng C, Zhou M. Multitarget therapy for induction treatment of lupus nephritis: a randomized trial. Ann Intern Med. 2015 Jan 6;162(1):18-26. doi: 10.7326/M14-1030.
Other Identifiers
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NJCT-0901
Identifier Type: -
Identifier Source: org_study_id