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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University Medical Centre Groningen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT00103792
First received: February 14, 2005
Last updated: February 12, 2009
Last verified: February 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • remission induction rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • disease free survival after 2 and 4 years [ Time Frame: 2 and 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to remission [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • cumulative organ damage [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • side-effects [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • ANCA titres over time [ Time Frame: 4 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Centre 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
Study First Received: February 14, 2005
Last Updated: February 12, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Additional relevant MeSH terms:
Vasculitis
Wegener Granulomatosis
Microscopic Polyangiitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract 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