11 février 2006 15:18

The Lupus Foundation of America wishes to inform you about a clinical research study to evaluate an alternative, investigational medication that may help to treat lupus nephritis.

Although there are treatments available for lupus nephritis that include the use of immunosuppressive and cytotoxic drugs (in conjunction with corticosteroids), new options are being explored.

If you or someone you know has lupus nephritis, you may want to know more.

The purpose of this study is to provide further information on the effect of mycophenolate mofetil (MMF), sold under the brand name CellCept, in the initial treatment of lupus nephritis (induction phase) and to assess how well it maintains this effect over longer periods (maintenance phase), when compared to the current standard treatments. The safety of MMF in the long-term treatment of lupus nephritis will also be assessed.

To be eligible for participation in this study, a person must:

Be 12 to 75 years of age,

Have a diagnosis of lupus, and have received a kidney biopsy in the last 6 months confirming a medical diagnosis of lupus nephritis.

There are two separate treatment phases in this study. The first phase will last for 6 months and the second will last for a further 3 years. The treatment in the first phase will consist of corticosteroids plus either the investigational medication or a comparator medication. The treatment in the second phase will consist of corticosteroids plus either the investigational medication or a different comparator medication. Participants will not know which treatment they have been randomized to.

Qualified participants will receive a study-related medical evaluation, including laboratory work, and study medication at no cost. Reimbursement for travel will also be provided.

This study is being conducted at sites located in the following U.S. states: AL, CA, CO, FL, GA, IL, MA, MD, MO, NC,NY, OH, OK, PA, SC, TX.

Thank you for your interest in this study.

Gigi-Karen