VasculitisNCT00301652
MMF Versus CTX in the Induction Treatment of ANCA Associated Vasculitis
A study testing mycophenolate mofetil in people with Vasculitis and Anti-Neutrophil Cytoplasmic Antibody, run by Nanjing University School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vasculitis, Anti-Neutrophil Cytoplasmic Antibody
- What is being tested?
- mycophenolate mofetil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jun 2003to Dec 2005
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A new diagnosis of ANCA associated vasculitis (eg. MPA or Wegener granulomatous, or renal limited vasculitis) proved by histology and serology.
- 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
- Serum ANCA positive by indirect immunofluorescence (IIF) and positivity in the anti-PR3 or anti-MPO by ELISA
- Age 18~65 years
Who cannot join
- 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
- Co-existence of another multisystem autoimmune disease, e.g. SLE
- Serum creatinine > 500umol/l
- Severe viral infection(HBV, HCV, CMV) within 3 months of first randomization or known HIV infection
- Congenial or acquired immunodeficiency
- Immediately life-threatening organ manifestations (e.g. lung haemorrhage or dialysis dependence)
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- Previous malignancy
- Pregnancy or inadequate contraception if female
- Anti-GBM antibody positivity
- Cerebral infarction due to vasculitis
- Rapidly progressive optic neuropathy or retinal vasculitis or orbital pseudotumour
- Massive gastro-intestinal bleeding
- Heart failure due to pericarditis or myocarditis
- Liver dysfunction measured on at least 2 separate occasions
- Age < 18y or Age > 65y
Trial locations and contacts
1 site in 1 country.
China1 site
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, 210002
About this study
Official title: Mycophenolate Mofetil Versus Cyclophosphamide in the Induction Treatment of ANCA Associated Vasculitis
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.
Read the 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).
- Conditions
- Vasculitis, Anti-Neutrophil Cytoplasmic Antibody
- Being tested
- mycophenolate mofetil
- Keywords
- ANCA, vasculitis, mycophenolate mofetil, cyclophosphamide, treatment
- Medical subject headings
- Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called MMF,cellcept,mycophenolate mofetil
MMF,1.0g/d
| Study group | Role | What they receive |
|---|---|---|
| mycophenolate mofetil | Experimental | Not described Receives: Drug: mycophenolate mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of MMF compared to CTX in inducing remission and improving renal function in subjects with ANCA associated vasculitis.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2006 (estimated)
- Study startJun 2003
- Primary completionApr 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VasculitisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing University School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Lei-Shi Li, M.D., Study chair, Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00301652
- Sponsor's protocol ID
- NJCT-0607
- Status last verified
- Mar 2009
- First submitted
- 10 Mar 2006
- Last updated
- 8 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mycophenolate Mofetil Versus Cyclophosphamide in the Induction Treatment of ANCA Associated Vasculitis
- ClinicalTrials.gov ID
- NCT00301652
- Acronym / sponsor ID
- NJCT-0607
- Conditions
- Vasculitis, Anti-Neutrophil Cytoplasmic Antibody
- Keywords
- ANCA, vasculitis, mycophenolate mofetil, cyclophosphamide, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nanjing University School of MedicineUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Apr 2004 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 13 Mar 2006 (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 access the efficacy of MMF compared to CTX in inducing remission and improving renal function in subjects with ANCA associated vasculitis with renal involvement.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mycophenolate mofetil | Experimental | Drug: mycophenolate mofetil |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A new diagnosis of ANCA associated vasculitis (eg. MPA or Wegener granulomatous, or renal limited vasculitis) proved by histology and serology.
- Renal involvement attributable to active ANCA associated vasculitis with at least one of the following:
- Serum ANCA positive by indirect immunofluorescence (IIF) and positivity in the anti-PR3 or anti-MPO by ELISA
- Age 18~65 years
Key exclusion criteria (15 listed)
- 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
- Co-existence of another multisystem autoimmune disease, e.g. SLE
- Serum creatinine > 500umol/l
- Severe viral infection(HBV, HCV, CMV) within 3 months of first randomization or known HIV infection
- Congenial or acquired immunodeficiency
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 mofetilAlso: MMF,cellcept,mycophenolate mofetilMMF,1.0g/d | Drug | mycophenolate mofetil |
Primary outcome
The efficacy of MMF compared to CTX in inducing remission and improving renal function in subjects with ANCA associated vasculitis.
Time frame: 24 months
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 8 Jun 2010.
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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.
Lei-Shi Li, M.D. study chair
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mycophenolate mofetil in people with Vasculitis and Anti-Neutrophil Cytoplasmic Antibody, run by Nanjing University School of Medicine at 1 site in China.
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 8 inclusion and 15 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 8 Jun 2010. 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 China. 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.
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?
The efficacy of MMF compared to CTX in inducing remission and improving renal function in subjects with ANCA associated vasculitis. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2010.