We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mycophenolate Mofetil for Treatment of Relapses of Wegener's Disease or Microscopic Polyangiitis (MPA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by University Medical Center Groningen.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00103792
First Posted: February 15, 2005
Last Update Posted: February 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Medical Center Groningen
  Purpose

The purpose of this study is to determine the efficacy and safety of a new drug, mycophenolate mofetil, for the treatment of relapses of ANCA-associated vasculitis (Wegener's granulomatosis or microscopic polyangiitis). Therefore, we compare the standard therapy with cyclophosphamide to mycophenolate mofetil.

The investigators expect mycophenolate mofetil to be less toxic and almost equally effective as cyclophosphamide.


Condition Intervention Phase
Wegener's Granulomatosis Vasculitis Drug: mycophenolate mofetil Drug: cyclophosphamide Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study of the Efficacy of Induction Therapy With Cyclophosphamide or Mycophenolate Mofetil for Non-Life-Threatening Relapses of PR3- or MPO-ANCA Associated Vasculitis

Resource links provided by NLM:


Further study details as provided by University Medical Center Groningen:

Primary Outcome Measures:
  • remission induction rate [ Time Frame: 6 months ]
  • disease free survival after 2 and 4 years [ Time Frame: 2 and 4 years ]

Secondary Outcome Measures:
  • time to remission [ Time Frame: 9 months ]
  • cumulative organ damage [ Time Frame: 4 years ]
  • side-effects [ Time Frame: 4 years ]
  • ANCA titres over time [ Time Frame: 4 years ]

Estimated Enrollment: 90
Study Start Date: December 2004
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
mycophenolate and steroids as remission induction, followed by azathioprine maintenance therapy
Drug: mycophenolate mofetil
2000 mg mycophenolate per day combined with steroids for induction remission, followed by azathioprine standard maintenance therapy
Active Comparator: 2
cyclophosphamide
Drug: cyclophosphamide
2 mg/kg/d, combined with steroids, for remission induction, followed by standard azathioprine maintenance therapy

Detailed Description:

Treatment of ANCA-associated vasculitis consists of two phases: remission induction with highly effective, but also relatively toxic drugs, and, secondly, after remission is achieved, maintenance therapy with less toxic drugs. The standard induction therapy of a relapse of Wegener's granulomatosis or microscopic polyangiitis consists of the combination of cyclophosphamide and prednisolone. Although this induction therapy is very effective, it is very toxic as well.

Searching for an alternative for cyclophosphamide, we will test the efficacy and safety of a new combination therapy with mycophenolate mofetil and prednisolone. We will compare the effect and safety of the standard induction therapy with the new therapy. When relapses occur, patients will be randomized for either the standard therapy with cyclophosphamide or for mycophenolate mofetil.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First or second relapse ANCA-associated vasculitis
  • PR3- or MPO-ANCA antibodies present or histological proof of relapse
  • Adult

Exclusion Criteria:

  • Severe alveolar bleeding or (imminent) respiratory failure
  • Renal failure (serum creatinine >500 umol/L or dialysis)
  • Maintenance therapy before start of study consisting of: cyclophosphamide > 100 mg/day or prednisolone >25 mg/day
  • Intolerance or allergy for cyclophosphamide, mycophenolate mofetil or azathioprine
  • Gravidity or inadequate anticonception
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00103792


Contacts
Contact: Patricia M. Stassen, M.D., Ph.D. +31433876543 p.stassen@mumc.nl
Contact: Coen A. Stegeman, M.D., Ph.D. +31503616161 c.a.stegeman@int.umcg.nl

Locations
Netherlands
University Medical Centre Groningen Recruiting
Groningen, Netherlands, 9700 RB
Contact: Patricia Stassen, M.D.    +31503611295    p.m.stassen@int.umcg.nl   
Contact: Coen Stegeman, M.D., Ph. D.    +31503616161    c.a.stegeman@int.umcg.nl   
Sub-Investigator: Patricia Stassen, M.D. pH.D.         
Sponsors and Collaborators
University Medical Center Groningen
Investigators
Principal Investigator: Coen Stegeman, MD PhD UMCG Groningen
  More Information

Publications:
Stegeman CA; Cohen Tervaert JW. Mycophenolate mofetil for remission induction in patients with active Wegener's Granulomatosis (WG) intolerant for cyclophosphamide. J Am Soc Nephrol(11):98A, 2000

Responsible Party: University Medical Center Groningen, Dept of Nephrology
ClinicalTrials.gov Identifier: NCT00103792     History of Changes
Other Study ID Numbers: WG-MMF-1
UMCG-ANCA-MMF-1
First Submitted: February 14, 2005
First Posted: February 15, 2005
Last Update Posted: February 16, 2009
Last Verified: February 2009

Keywords provided by University Medical Center Groningen:
Induction therapy
ANCA-associated vasculitis
Wegener's granulomatosis
microscopic polyangiitis
mycophenolate mofetil
cyclophosphamide

Additional relevant MeSH terms:
Vasculitis
Granulomatosis with Polyangiitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Microscopic Polyangiitis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Systemic Vasculitis
Autoimmune Diseases
Immune System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cyclophosphamide
Azathioprine
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic