Status:
COMPLETED
Assess the Efficacy and Safety of Multi-target Therapy in Lupus Nephritis
Lead Sponsor:
Zhi-Hong Liu, M.D.
Collaborating Sponsors:
Ruijin Hospital
West China Hospital
Conditions:
Lupus Nephritis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to assess the efficacy and safety of multi-target therapy in the treatment of class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+Ⅴ lupus nephritis.
Detailed Description
1. To assess the efficacy of FK506 combined with MMF vs intravenous cyclophosphamide (CTX) pulses in treatment of class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+Ⅴ Lupus Nephritis (LN). 2. To investigate the safety and tolerabi...
Eligibility Criteria
Inclusion
- Written informed consent by subject or guardian
- 18 to 65 years of age (inclusive 18 and 65), male or female
- Diagnosis of SLE according to the American College of Rheumatology criteria (1997)
- 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
- Pathologic chronic index (CI) ≤3' without thrombotic microangiopathy (TMA)
- SLE Disease Activity Index (DAI) \>10'
- Proteinuria ≥1.5g/d，with or without active urinary sediment
- Serum creatinine (Scr)≤3.0mg/dl (265.2 mol/L)
Exclusion
- Previous treatment with MMF, CTX, tacrolimus, Cyclosporin A (CsA), large doses of immunoglobulin and methylprednisolone (MP), plasmapheresis or renal replacement therapy within the past 12 weeks. Oral glucocorticoids, azathioprine, intravenous MP (≤80mg/d)， short-time CsA (\<2 weeks) or leflunomide (\<4 weeks) are allowed
- ALT or AST increase twice above the upper limit of the normal range
- Hyperglycemia is defined as fasting blood glucose level ≥7.0 mmol/L and/or postprandial blood sugar level\>11.1 mmol/L
- Known hypersensitivity or contraindication to any components of MMF, tacrolimus, CTX or glucocorticoids
- History of present illness:
- 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
- non-healed active peptic ulcer within 3 months before the enrollment
- drug or drinking abuse
- malnutrition (BMI \<18.5kg/m2) or body weight \<50Kg
- Other active diseases, such as:
- severe cardiovascular diseases
- chronic obstructive pulmonary disease(COPD)or asthma requiring oral glucocorticoids
- marrow depression not due to SLE activation: white blood cell count \<3000/mm3 or neutrophil count \<1300/mm3 or platelet count \<50000/mm3
- Severe infection or need of antibiotic therapy
- Female patients who are pregnant/breastfeeding or those patients (both gender) who refused contraception
- 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
- Known to be non-compliance or violation of the protocol base on investigator's judgement
- Patient who participate of any other investigational drug study.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT00876616
Start Date
April 1 2009
End Date
February 1 2012
Last Update
August 29 2013
Active Locations (1)
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1
Research Institute of Nephrology,Jinling Hospital
Nanjing, Jiangsu, China, 210002