MAINTAIN: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis.

• Sponsor: Frédéric A. Houssiau, MD, PhD (Other)
• Overall Status: Completed
• CT.gov ID: NCT00204022
• Collaborator: (none)
• Enrollment: 105
• Location: 1
• Arms: 2
• Duration (Months): 125.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

The purpose of the study is to determine whether mycophenolate mofetil is superior to azathioprine to prevent flares of lupus nephritis.

Condition or Disease	Intervention/Treatment	Phase
Lupus Nephritis	Drug: Mycophenolate mofetil; Drug: Azathioprine	Phase 3

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

• Study Type: Interventional
• 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: Feb 1, 2001
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Time to renal flare [5 years]

Secondary Outcome Measures

1. Number of withdrawals due to toxicity [5 years and 10 years]

2. Cumulated glucocorticoid intake [5 years and 10 years]

3. Number of treatment failures [5 years and 10 years]

4. 24-hour proteinuria over time [5 years and 10 years]

5. Serum creatinine titers [5 years and 10 years]

6. Time to renal flare [10 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Sep 20, 2005
• Last Update Posted: Oct 14, 2011
• Last Verified: Oct 1, 2011

• Keywords provided by Frédéric A. Houssiau, MD, PhD, Professeur Ordinaire, Chef de Service Clinique, Université Catholique de Louvain: Lupus nephritis; Treatment; Maintenance therapy; Mycophenolate mofetil; Azathioprine
• Additional relevant MeSH terms: Nephritis; Lupus Nephritis; Mycophenolic Acid; Azathioprine

Study Results

No Results Posted as of Oct 14, 2011