Wegener's GranulomatosisPhase 3NCT00103792
Mycophenolate Mofetil for Treatment of Relapses of Wegener's Disease or Microscopic Polyangiitis (MPA)
A Phase 3 study testing mycophenolate mofetil and cyclophosphamide in people with Wegener's Granulomatosis and Vasculitis, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wegener's Granulomatosis, Vasculitis
- What is being tested?
- mycophenolate mofetil and cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2004to Jan 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First or second relapse ANCA-associated vasculitis
- PR3- or MPO-ANCA antibodies present or histological proof of relapse
- Adult
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- mycophenolate mofetil, cyclophosphamide
- Keywords
- Induction therapy, ANCA-associated vasculitis, Wegener's granulomatosis, microscopic polyangiitis, mycophenolate mofetil, cyclophosphamide
- Medical subject headings
- Granulomatosis with Polyangiitis, Vasculitis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Microscopic Polyangiitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2000 mg mycophenolate mofetil per day combined with steroids for induction remission, followed by azathioprine standard maintenance therapy
cyclophosphamideDrug
2 mg/kg/d, combined with steroids, for remission induction, followed by standard azathioprine maintenance therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 MMF induction | Experimental | mycophenolate and steroids as remission induction, followed by azathioprine as maintenance therapy Receives: Drug: mycophenolate mofetil |
| 2 CYC induction | Active comparator | cyclophosphamide and steroids, followed by maintenance therapy (azathioprine) Receives: Drug: cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
remission induction rate
Measured: 6 months
disease free survival after 2 and 4 years
Measured: 2 and 4 years
Secondary outcomes (4)
time to remission
Measured: 9 months
cumulative organ damage
Measured: 4 years
side-effects
Measured: 4 years
ANCA titres over time
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2005 (estimated)
- Study startDec 2004
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wegener's GranulomatosisStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Coen Stegeman, MD PhD, Principal investigator, UMCG Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00103792
- Sponsor's protocol ID
- WG-MMF-1
- Other IDs
- UMCG-ANCA-MMF-1
- Status last verified
- Aug 2024
- First submitted
- 14 Feb 2005
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00103792
- Acronym / sponsor ID
- WG-MMF-1
- Conditions
- Wegener's Granulomatosis, Vasculitis
- Keywords
- Induction therapy, ANCA-associated vasculitis, Wegener's granulomatosis, microscopic polyangiitis, mycophenolate mofetil, cyclophosphamide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Dec 2004 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 15 Feb 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 MMF induction | Experimental | Drug: mycophenolate mofetilmycophenolate and steroids as remission induction, followed by azathioprine as maintenance therapy |
| 2 CYC induction | Active comparator | Drug: cyclophosphamidecyclophosphamide and steroids, followed by maintenance therapy (azathioprine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- First or second relapse ANCA-associated vasculitis
- PR3- or MPO-ANCA antibodies present or histological proof of relapse
- Adult
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mycophenolate mofetil2000 mg mycophenolate mofetil per day combined with steroids for induction remission, followed by azathioprine standard maintenance therapy | Drug | 1 MMF induction |
| cyclophosphamide2 mg/kg/d, combined with steroids, for remission induction, followed by standard azathioprine maintenance therapy | Drug | 2 CYC induction |
Primary outcome
remission induction rate
Time frame: 6 months
disease free survival after 2 and 4 years
Time frame: 2 and 4 years
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- BackgroundStegeman 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
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Coen Stegeman, MD PhD principal investigator
UMCG Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mycophenolate mofetil and cyclophosphamide in people with Wegener's Granulomatosis and Vasculitis, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
remission induction rate (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00103792, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.