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

NCT ID: NCT00103792

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2015-01-31

Brief Summary

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.

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.

Conditions

Wegener's Granulomatosis; Vasculitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1 MMF induction

mycophenolate and steroids as remission induction, followed by azathioprine as maintenance therapy

Group Type: EXPERIMENTAL

mycophenolate mofetil

Intervention Type: DRUG

2000 mg mycophenolate mofetil per day combined with steroids for induction remission, followed by azathioprine standard maintenance therapy

2 CYC induction

cyclophosphamide and steroids, followed by maintenance therapy (azathioprine)

Group Type: ACTIVE_COMPARATOR

cyclophosphamide

Intervention Type: DRUG

2 mg/kg/d, combined with steroids, for remission induction, followed by standard azathioprine maintenance therapy

Interventions

mycophenolate mofetil

2000 mg mycophenolate mofetil per day combined with steroids for induction remission, followed by azathioprine standard maintenance therapy

Intervention Type: DRUG

cyclophosphamide

2 mg/kg/d, combined with steroids, for remission induction, followed by standard azathioprine maintenance therapy

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Coen Stegeman, MD PhD

Role: PRINCIPAL_INVESTIGATOR

UMCG Groningen

Locations

University Medical Centre Groningen

Groningen, , Netherlands

Countries

Netherlands

References

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

Reference Type: BACKGROUND

Other Identifiers

UMCG-ANCA-MMF-1

Identifier Type: -

Identifier Source: secondary_id

WG-MMF-1

Identifier Type: -

Identifier Source: org_study_id