Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis. (MAINTAIN)
This study has been completed.
Sponsor:
Frédéric A. Houssiau, MD, PhD
Information provided by (Responsible Party):
Frédéric A. Houssiau, MD, PhD, Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00204022
First received: September 12, 2005
Last updated: October 13, 2011
Last verified: October 2011
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Purpose
The purpose of the study is to determine whether mycophenolate mofetil is superior to azathioprine to prevent flares of lupus nephritis.
| Condition | Intervention | Phase |
|---|---|---|
|
Lupus Nephritis |
Drug: Mycophenolate mofetil Drug: Azathioprine |
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: | A Randomized Multicenter Trial Comparing Mycophenolate Mofetil and Azathioprine as Remission-maintaining Treatment for Proliferative Lupus Glomerulonephritis. The MAINTAIN Nephritis Trial. |
Resource links provided by NLM:
Drug Information available for:
Azathioprine
Mycophenolic acid
Mycophenolate sodium
Azathioprine Sodium
Mycophenolate mofetil hydrochloride
Mycophenolate mofetil
U.S. FDA Resources
Further study details as provided by Université Catholique de Louvain:
Primary Outcome Measures:
- Time to renal flare [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of withdrawals due to toxicity [ Time Frame: 5 years and 10 years ] [ Designated as safety issue: No ]
- Cumulated glucocorticoid intake [ Time Frame: 5 years and 10 years ] [ Designated as safety issue: No ]
- Number of treatment failures [ Time Frame: 5 years and 10 years ] [ Designated as safety issue: No ]
- 24-hour proteinuria over time [ Time Frame: 5 years and 10 years ] [ Designated as safety issue: No ]
- Serum creatinine titers [ Time Frame: 5 years and 10 years ] [ Designated as safety issue: No ]
- Time to renal flare [ Time Frame: 10 years ] [ Designated as safety issue: No ]
| Enrollment: | 105 |
| Study Start Date: | February 2001 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Mycophenolate mofetil (target dose 2g/day)
|
Drug: Mycophenolate mofetil
Mycophenolate mofetil
|
|
Active Comparator: 2
Azathioprine (target dose 2mg/kg/day)
|
Drug: Azathioprine
Azathioprine
|
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.
Eligibility| Ages Eligible for Study: | 14 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- SLE aged ≥ 14 years
- Proteinuria ≥ 500 mg/day
- Biopsy-proven proliferative lupus nephritis
Exclusion Criteria:
- Recent treatment with high-dose glucocorticoids
- Recent treatment with immunosuppressive drugs
- More exclusion criteria in the protocol
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204022
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204022
Locations
| Belgium | |
| Université catholique de Louvain | |
| Bruxelles, Belgium, B-1200 | |
Sponsors and Collaborators
Frédéric A. Houssiau, MD, PhD
Investigators
| Principal Investigator: | Frédéric A Houssiau, MD, PhD | Université Catholique de Louvain |
More Information
No publications provided
| Responsible Party: | Frédéric A. Houssiau, MD, PhD, Professeur Ordinaire, Chef de Service Clinique, Université Catholique de Louvain |
| ClinicalTrials.gov Identifier: | NCT00204022 History of Changes |
| Other Study ID Numbers: | EWPSLE-LN-02 |
| Study First Received: | September 12, 2005 |
| Last Updated: | October 13, 2011 |
| Health Authority: | Belgium: Ministry of Social Affairs, Public Health and the Environment |
Keywords provided by Université Catholique de Louvain:
|
Lupus nephritis Treatment Maintenance therapy Mycophenolate mofetil Azathioprine |
Additional relevant MeSH terms:
|
Lupus Nephritis Nephritis Autoimmune Diseases Connective Tissue Diseases Glomerulonephritis Immune System Diseases Kidney Diseases Lupus Erythematosus, Systemic Urologic Diseases Azathioprine Mycophenolate mofetil Mycophenolic Acid |
Antibiotics, Antineoplastic Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Antirheumatic Agents Enzyme Inhibitors Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015