Mycophenolate Mofetil Versus Cyclophosphamide in the Induction Treatment of Antineutrophil Cytoplasmic Antibodies (ANCA) Associated Vasculitis - Full Text View

Sponsored by:	Nanjing University School of Medicine
Information provided by:	Nanjing University School of Medicine
ClinicalTrials.gov Identifier:	NCT00301652

Purpose

The purpose of this study is to access the efficacy of MMF compared to CTX in inducing remission and improving renal function in subjects with ANCA associated vasculitis with renal involvement.

Condition	Intervention
Vasculitis Anti-Neutrophil Cytoplasmic Antibody	Drug: mycophenolate mofetil

MedlinePlus related topics: Vasculitis

Drug Information available for: Cyclophosphamide Immunoglobulins Globulin, Immune Mycophenolate Mofetil Mycophenolate mofetil hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Mycophenolate Mofetil Versus Cyclophosphamide in the Induction Treatment of ANCA Associated Vasculitis

Further study details as provided by Nanjing University School of Medicine:

Primary Outcome Measures:

The efficacy of MMF compared to CTX in inducing remission and improving renal function in subjects with ANCA associated vasculitis. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment:	60
Study Start Date:	June 2003
Study Completion Date:	December 2005
Primary Completion Date:	April 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: mycophenolate mofetil MMF,1.0g/d

Detailed Description:

The ANCA-associated vasculitides can be life threatening. Glucocorticoids and cyclophosphamide therapy is effective in about 80% patients. However, the side effects such as bone marrow suppression, infection, cystitis, infertility, myelodysplasia preclude further use of cyclophosphamide in some patients and the relapse rate is high.

Recent studies have shown that mycophenolic acid(MPA), the active metabolite of mycophenolate mofetil(MMF), could exhibit multifarious effects on endothelial cells, including inhibition of ICAM-1 expression, neutrophil attachment,IL-6 secretion, and the process of angiogenesis, which contribute to the efficacy of MMF in the treatment of vasculitic lesions such as lupus nephritis with vasculitic lesions. This study was a feasibility study to assess the safety and effectiveness of MMF in inducing remission in subjects with ANCA-associated SVV compared with pulse intravenous cyclophosphamide. After enrolment, subjects were followed longitudinally, and formal measurements of disease activity were determined using the Birmingham Vasculitis Activity Score (BVAS).

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

A new diagnosis of ANCA associated vasculitis (eg. MPA or Wegener granulomatous, or renal limited vasculitis) proved by histology and serology.
Renal involvement attributable to active ANCA associated vasculitis with at least one of the following:
- Elevated serum creatinine between 150 and 500 umol/l - renal biopsy
- Demonstrating paucin -immune necrotizing glomerulonephritis
- Red cell casts
- Haematuria with ＞ 30 red blood cells/HPF and proteinuria ＞ 1g/24h
Serum ANCA positive by indirect immunofluorescence (IIF) and positivity in the anti-PR3 or anti-MPO by ELISA
Age 18~65 years

Exclusion Criteria:

More than two weeks treatment with cyclophosphamide (CYC) or other cytotoxic drug within previous 6 months or with oral corticosteroids (OCS) for more than 4 weeks
Co-existence of another multisystem autoimmune disease, e.g. SLE
Serum creatinine > 500umol/l
Severe viral infection(HBV, HCV, CMV) within 3 months of first randomization or known HIV infection
Congenial or acquired immunodeficiency
Immediately life-threatening organ manifestations (e.g. lung haemorrhage or dialysis dependence)
Previous malignancy
Pregnancy or inadequate contraception if female
Anti-GBM antibody positivity
Cerebral infarction due to vasculitis
Rapidly progressive optic neuropathy or retinal vasculitis or orbital pseudotumour
Massive gastro-intestinal bleeding
Heart failure due to pericarditis or myocarditis
Liver dysfunction measured on at least 2 separate occasions
Age < 18y or Age > 65y

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301652

Locations

China, Jiangsu
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, China, 210002

Sponsors and Collaborators

Nanjing University School of Medicine

Investigators

Study Chair:

Lei-Shi Li, M.D.

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

More Information

Responsible Party:	Nanjing University School of Medicine ( Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine )
Study ID Numbers:	NJCT-0607
Study First Received:	March 10, 2006
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00301652
Health Authority:	China: State Food and Drug Administration

Keywords provided by Nanjing University School of Medicine:

ANCA
vasculitis
mycophenolate mofetil
cyclophosphamide
treatment

Study placed in the following topic categories:

Antibodies, Antineutrophil Cytoplasmic
Antibodies
Vasculitis
Mycophenolic Acid

Mycophenolate mofetil
Vascular Diseases
Cyclophosphamide
Immunoglobulins

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antibiotics, Antineoplastic
Immunosuppressive Agents

Pharmacologic Actions
Therapeutic Uses
Myeloablative Agonists
Cardiovascular Diseases
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 15, 2009