Lupus NephritisPhase 3MAINTAINNCT00204022
Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis.
A Phase 3 study testing Mycophenolate mofetil and Azathioprine in people with Lupus Nephritis, run by Frédéric A. Houssiau, MD, PhD at 1 site in Belgium.
Trial summary
The purpose of the study is to determine whether mycophenolate mofetil is superior to azathioprine to prevent flares of lupus nephritis. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Mycophenolate mofetil and Azathioprine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2001to Aug 2011
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- SLE aged ≥ 14 years
- Proteinuria ≥ 500 mg/day
- Biopsy-proven proliferative lupus nephritis
Who cannot join
- Recent treatment with high-dose glucocorticoids
- Recent treatment with immunosuppressive drugs
- More exclusion criteria in the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Multicenter Trial Comparing Mycophenolate Mofetil and Azathioprine as Remission-maintaining Treatment for Proliferative Lupus Glomerulonephritis. The MAINTAIN Nephritis Trial.
The purpose of the study is to determine whether mycophenolate mofetil is superior to azathioprine to prevent flares of lupus nephritis.
Read the detailed description
Proliferative glomerulonephritis is a common and severe manifestation of systemic lupus erythematosus (SLE) that usually requires intensive therapy with high doses of glucocorticosteroids and cytotoxic drugs, such as intravenous (IV) cyclophosphamide (CYC). The objective of the MAINTAIN Nephritis Trial is to compare mycophenolate mofetil (MMF) and azathioprine (AZA), in terms of efficacy and toxicity, as remission-maintaining treatment of proliferative lupus glomerulonephritis, after a remission-inducing therapy with a short-course IV CYC regimen. The hypothesis addressed by the MAINTAIN Nephritis Trial is that MMF is superior to AZA.
- Conditions
- Lupus Nephritis
- Being tested
- Mycophenolate mofetil, Azathioprine
- Keywords
- Lupus nephritis, Treatment, Maintenance therapy, Mycophenolate mofetil, Azathioprine
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycophenolate mofetil
AzathioprineDrug
Azathioprine
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Mycophenolate mofetil (target dose 2g/day) Receives: Drug: Mycophenolate mofetil |
| 2 | Active comparator | Azathioprine (target dose 2mg/kg/day) Receives: Drug: Azathioprine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to renal flare
Measured: 5 years
Secondary outcomes (6)
Number of withdrawals due to toxicity
Measured: 5 years and 10 years
Cumulated glucocorticoid intake
Measured: 5 years and 10 years
Number of treatment failures
Measured: 5 years and 10 years
24-hour proteinuria over time
Measured: 5 years and 10 years
Serum creatinine titers
Measured: 5 years and 10 years
Time to renal flare
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startFeb 2001
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lupus NephritisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frédéric A. Houssiau, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Frédéric A. Houssiau, MD, PhD, Université Catholique de Louvain
- Investigators
- Frédéric A Houssiau, MD, PhD, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204022
- Sponsor's protocol ID
- EWPSLE-LN-02
- Acronym
- MAINTAIN
- Status last verified
- Oct 2011
- First submitted
- 12 Sep 2005
- Last updated
- 14 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Tamirou F, Lauwerys BR, Dall'Era M, Mackay M, Rovin B, Cervera R, Houssiau FA; MAINTAIN Nephritis Trial Investigators. A proteinuria cut-off level of 0.7 g/day after 12 months of treatment best predicts long-term renal outcome in lupus nephritis: data from the MAINTAIN Nephritis Trial. Lupus Sci Med. 2015 Nov 12;2(1):e000123. doi: 10.1136/lupus-2015-000123. eCollection 2015.
PubMed 26629352Tamirou F, D'Cruz D, Sangle S, Remy P, Vasconcelos C, Fiehn C, Ayala Guttierez Mdel M, Gilboe IM, Tektonidou M, Blockmans D, Ravelingien I, le Guern V, Depresseux G, Guillevin L, Cervera R, Houssiau FA; MAINTAIN Nephritis Trial Group. Long-term follow-up of the MAINTAIN Nephritis Trial, comparing azathioprine and mycophenolate mofetil as maintenance therapy of lupus nephritis. Ann Rheum Dis. 2016 Mar;75(3):526-31. doi: 10.1136/annrheumdis-2014-206897. Epub 2015 Mar 10.
PubMed 25757867
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multicenter Trial Comparing Mycophenolate Mofetil and Azathioprine as Remission-maintaining Treatment for Proliferative Lupus Glomerulonephritis. The MAINTAIN Nephritis Trial.
- ClinicalTrials.gov ID
- NCT00204022
- Acronym / sponsor ID
- MAINTAIN / EWPSLE-LN-02
- Conditions
- Lupus Nephritis
- Keywords
- Lupus nephritis, Treatment, Maintenance therapy, Mycophenolate mofetil, Azathioprine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Frédéric A. Houssiau, MD, PhDUniversity, hospital or other
- Study start
- Feb 2001
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 20 Sep 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 the study is to determine whether mycophenolate mofetil is superior to azathioprine to prevent flares of lupus nephritis.
Detailed description
Proliferative glomerulonephritis is a common and severe manifestation of systemic lupus erythematosus (SLE) that usually requires intensive therapy with high doses of glucocorticosteroids and cytotoxic drugs, such as intravenous (IV) cyclophosphamide (CYC). The objective of the MAINTAIN Nephritis Trial is to compare mycophenolate mofetil (MMF) and azathioprine (AZA), in terms of efficacy and toxicity, as remission-maintaining treatment of proliferative lupus glomerulonephritis, after a remission-inducing therapy with a short-course IV CYC regimen. The hypothesis addressed by the MAINTAIN Nephritis Trial is that MMF is superior to AZA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Mycophenolate mofetilMycophenolate mofetil (target dose 2g/day) |
| 2 | Active comparator | Drug: AzathioprineAzathioprine (target dose 2mg/kg/day) |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- SLE aged ≥ 14 years
- Proteinuria ≥ 500 mg/day
- Biopsy-proven proliferative lupus nephritis
Key exclusion criteria (3 listed)
- Recent treatment with high-dose glucocorticoids
- Recent treatment with immunosuppressive drugs
- More exclusion criteria in the protocol
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 mofetilMycophenolate mofetil | Drug | 1 |
| AzathioprineAzathioprine | Drug | 2 |
Primary outcome
Time to renal flare
Time frame: 5 years
6 secondary outcomes
Number of withdrawals due to toxicity
Time frame: 5 years and 10 years
Cumulated glucocorticoid intake
Time frame: 5 years and 10 years
Number of treatment failures
Time frame: 5 years and 10 years
24-hour proteinuria over time
Time frame: 5 years and 10 years
Serum creatinine titers
Time frame: 5 years and 10 years
Time to renal flare
Time frame: 10 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 14 Oct 2011.
- Derived from this study: PubMed 26629352Tamirou F, Lauwerys BR, Dall'Era M, Mackay M, Rovin B, Cervera R, Houssiau FA; MAINTAIN Nephritis Trial Investigators. A proteinuria cut-off level of 0.7 g/day after 12 months of treatment best predicts long-term renal outcome in lupus nephritis: data from the MAINTAIN Nephritis Trial. Lupus Sci Med. 2015 Nov 12;2(1):e000123. doi: 10.1136/lupus-2015-000123. eCollection 2015.
- Derived from this study: PubMed 25757867Tamirou F, D'Cruz D, Sangle S, Remy P, Vasconcelos C, Fiehn C, Ayala Guttierez Mdel M, Gilboe IM, Tektonidou M, Blockmans D, Ravelingien I, le Guern V, Depresseux G, Guillevin L, Cervera R, Houssiau FA; MAINTAIN Nephritis Trial Group. Long-term follow-up of the MAINTAIN Nephritis Trial, comparing azathioprine and mycophenolate mofetil as maintenance therapy of lupus nephritis. Ann Rheum Dis. 2016 Mar;75(3):526-31. doi: 10.1136/annrheumdis-2014-206897. Epub 2015 Mar 10.
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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.
Frédéric A Houssiau, MD, PhD principal investigator
Université Catholique de Louvain
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 Azathioprine in people with Lupus Nephritis, run by Frédéric A. Houssiau, MD, PhD at 1 site in Belgium.
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 3 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 14 Oct 2011. 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 Belgium. 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?
Time to renal flare (time frame: 5 years). 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 NCT00204022, which also lists 2 linked publications.
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 14 Oct 2011.