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MMF Versus CTX in the Induction Treatment of ANCA Associated Vasculitis

This study has been completed.
Sponsor:
Information provided by:
Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT00301652
First received: March 10, 2006
Last updated: June 7, 2010
Last verified: March 2009
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mycophenolate Mofetil Versus Cyclophosphamide in the Induction Treatment of ANCA Associated Vasculitis

Resource links provided by NLM:

MedlinePlus related topics: Vasculitis
U.S. FDA Resources

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
Experimental: mycophenolate mofetil Drug: mycophenolate mofetil
MMF,1.0g/d
Other Name: MMF,cellcept,mycophenolate mofetil

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 enrollment, 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:

  1. A new diagnosis of ANCA associated vasculitis (eg. MPA or Wegener granulomatous, or renal limited vasculitis) proved by histology and serology.

  2. 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
  3. Serum ANCA positive by indirect immunofluorescence (IIF) and positivity in the anti-PR3 or anti-MPO by ELISA
  4. Age 18~65 years

Exclusion Criteria:

  1. 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
  2. Co-existence of another multisystem autoimmune disease, e.g. SLE
  3. Serum creatinine > 500umol/l
  4. Severe viral infection(HBV, HCV, CMV) within 3 months of first randomization or known HIV infection
  5. Congenial or acquired immunodeficiency
  6. Immediately life-threatening organ manifestations (e.g. lung haemorrhage or dialysis dependence)
  7. Previous malignancy
  8. Pregnancy or inadequate contraception if female
  9. Anti-GBM antibody positivity
  10. Cerebral infarction due to vasculitis
  11. Rapidly progressive optic neuropathy or retinal vasculitis or orbital pseudotumour
  12. Massive gastro-intestinal bleeding
  13. Heart failure due to pericarditis or myocarditis
  14. Liver dysfunction measured on at least 2 separate occasions
  15. 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

No publications provided

Responsible Party: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT00301652     History of Changes
Other Study ID Numbers: NJCT-0607
Study First Received: March 10, 2006
Last Updated: June 7, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Nanjing University School of Medicine:
ANCA
vasculitis
mycophenolate mofetil
cyclophosphamide
treatment

Additional relevant MeSH terms:
Vasculitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Vascular Diseases
Cardiovascular Diseases
Systemic Vasculitis
Autoimmune Diseases
Immune System Diseases
Cyclophosphamide
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013