Assess the Efficacy and Safety of Multi-target Therapy in Lupus Nephritis

NCT00876616 | Completed DMC

• 1 other identifier: NJCT-0901
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 1

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.

Conditions

Lupus Nephritis

Keywords

lupus nephritis;multi-target therapy; MMF; FK506

Outcome Measures

Primary Outcomes (1)

• 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.

  The primary endpoint is the rate of complete remission at 24 weeks.

  24 weeks

Secondary Outcomes (1)

• 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

Other Outcomes (1)

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

  24 weeks

Study Arms (2)

Tacrolimus+Mycophenolate mofetil

EXPERIMENTAL

FK506 4mg/d+MMF 1.0g/d

Drug: Tacrolimus+Mycophenolate mofetil

Cyclophosphamide

ACTIVE COMPARATOR

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

Drug: Cyclophosphamide

Interventions

Tacrolimus+Mycophenolate mofetil DRUG

FK506 4mg/d,MMF 1.0g/d

Also known as: FK506+MMF

Tacrolimus+Mycophenolate mofetil

Cyclophosphamide DRUG

CTX 0.75g/m2 BSA

Also known as: CTX

Cyclophosphamide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent by subject or guardian
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhi-Hong Liu, M.D.: lead
• Ruijin Hospital: collaborator
• West China Hospital: collaborator
• RenJi Hospital: collaborator
• China Medical University, China: collaborator
• Huashan Hospital: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Beijing Friendship Hospital: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Research Institute of Nephrology,Jinling Hospital

Nanjing, Jiangsu, 210002, China

Location

Related Publications (1)

• 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.

  PMID: 25383558 DERIVED

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Zhihong Liu, Master

  Nanjing University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 6, 2009
• First Posted: April 7, 2009
• Study Start: April 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: February 1, 2012
• Last Updated: August 29, 2013

Record last verified: 2013-08

Locations

CN (1)