Clinical Trials/NCT00876616

NCT00876616

Completed

N/A

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 enrollmentApril 2009

ConditionsLupus Nephritis

InterventionsTacrolimus+Mycophenolate mofetil Cyclophosphamide

DrugsTacrolimus+Mycophenolate mofetil Cyclophosphamide

Overview

Phase: N/A
Intervention: Tacrolimus+Mycophenolate mofetil
Conditions: Lupus Nephritis
Sponsor: Zhi-Hong Liu, M.D.
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.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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

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 tolerability of FK506 combined with MMF vs intravenous CTX pulses in the treatment of class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+Ⅴ LN.

Registry

clinicaltrials.gov

Start Date

April 2009

End Date

February 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Zhi-Hong Liu, M.D.

Responsible Party

Sponsor Investigator

Principal Investigator

Zhi-Hong Liu, M.D.

professor

Nanjing University School of Medicine

Eligibility Criteria

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:

Arms & Interventions

Tacrolimus+Mycophenolate mofetil

FK506 4mg/d+MMF 1.0g/d

Intervention: Tacrolimus+Mycophenolate mofetil

Cyclophosphamide

CTX iv 0.75 g/m2 body surface area (BSA)

Intervention: Cyclophosphamide

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)