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

Frédéric A. Houssiau, MD, PhD

Status and phase: Completed; Phase 3

Conditions: Lupus Nephritis

Treatments: Drug: Azathioprine; Drug: Mycophenolate mofetil

Study type: Interventional

Funder types: Other

Identifiers

NCT00204022

EWPSLE-LN-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

1

Experimental group

Description:

Mycophenolate mofetil (target dose 2g/day)

Treatment:

Drug: Mycophenolate mofetil

2

Active Comparator group

Description:

Azathioprine (target dose 2mg/kg/day)

Treatment:

Drug: Azathioprine