NCT00876616CompletedNot Applicable
An Multi-site, Open, Prospective Study to Assess the Efficacy and Safety of Multi-target Therapy in the Treatment of Class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+Ⅴ Lupus Nephritis
Zhi-Hong Liu, M.D.1 site in 1 country362 target enrollmentStarted: April 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 362
- Locations
- 1
- Primary Endpoint
- To assess the efficacy of FK506 combined with MMF vs intravenous CTX pulses in treatment of class Ⅲ, Ⅳ,Ⅴ, Ⅲ+Ⅴand Ⅳ+Ⅴ LN.
Study Overview
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
- 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).
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
Tacrolimus+Mycophenolate mofetil
Experimental
FK506 4mg/d+MMF 1.0g/d
Intervention: Tacrolimus+Mycophenolate mofetil (Drug)
Cyclophosphamide
Active Comparator
CTX iv 0.75 g/m2 body surface area (BSA)
Intervention: Cyclophosphamide (Drug)
Outcomes
Primary Outcomes
To assess the efficacy of FK506 combined with MMF vs intravenous CTX pulses in treatment of class Ⅲ, Ⅳ,Ⅴ, Ⅲ+Ⅴand Ⅳ+Ⅴ LN.
Time Frame: 24 weeks
The primary endpoint is the rate of complete remission at 24 weeks.
Secondary Outcomes
- To investigate the other efficacy indicators of FK506 combined with MMF vs intravenous CTX pulses in the treatment of class Ⅲ, Ⅳ,Ⅴ, Ⅲ+Ⅴand Ⅳ+Ⅴ LN.(24 weeks)
Investigators
Zhi-Hong Liu, M.D.
professor
Nanjing University School of Medicine
Study Sites (1)
Loading locations...
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