Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis. (MAINTAIN)
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ClinicalTrials.gov Identifier: NCT00204022 |
Recruitment Status :
Completed
First Posted : September 20, 2005
Last Update Posted : October 14, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lupus Nephritis | Drug: Mycophenolate mofetil Drug: Azathioprine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 105 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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. |
Study Start Date : | February 2001 |
Actual Primary Completion Date : | August 2011 |
Actual Study Completion Date : | August 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Mycophenolate mofetil (target dose 2g/day)
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Drug: Mycophenolate mofetil
Mycophenolate mofetil |
Active Comparator: 2
Azathioprine (target dose 2mg/kg/day)
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Drug: Azathioprine
Azathioprine |
- Time to renal flare [ Time Frame: 5 years ]
- 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 ]

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Ages Eligible for Study: | 14 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00204022
Belgium | |
Université catholique de Louvain | |
Bruxelles, Belgium, B-1200 |
Principal Investigator: | Frédéric A Houssiau, MD, PhD | Université Catholique de Louvain |
Responsible Party: | Frédéric A. Houssiau, MD, PhD, Professeur Ordinaire, Chef de Service Clinique, Université Catholique de Louvain |
ClinicalTrials.gov Identifier: | NCT00204022 |
Other Study ID Numbers: |
EWPSLE-LN-02 |
First Posted: | September 20, 2005 Key Record Dates |
Last Update Posted: | October 14, 2011 |
Last Verified: | October 2011 |
Lupus nephritis Treatment Maintenance therapy Mycophenolate mofetil Azathioprine |
Nephritis Lupus Nephritis Kidney Diseases Urologic Diseases Glomerulonephritis Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Mycophenolic Acid Azathioprine Antibiotics, Antineoplastic Antineoplastic Agents |
Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimetabolites Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |