IRB Number:

08-004464

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

The purpose of this study is to investigate the drug rituximab in the treatment of lupus membranous nephritis. Treatment for lupus nephritis (LN) is undergoing rapid evolution as new therapeutic agents become available. Rituximab, an anti-CD 20 antibody, is a novel agent under study for treatment of proliferative LN, ISN/WHO Class III and IV with preliminary results showing significant improvement of the lupus activity. However, 10-20 percent of lupus nephritis is WHO Class V, membranous LN. Therapy given for membranous LN has included corticosteroids, cyclophosphamide, and cyclosporin A. However, the potential adverse effects of these agents have contributed to the reluctance of many rheumatologists and nephrologists to employ these interventions for membranous LN. Anti-CD 20 therapy has been administered to a small group of patients with idiopathic membranous nephropathy with excellent results. However, there is little data regarding the response of membranous LN to anti-CD 20 therapy. Based upon the effects of rituximab in idiopathic membranous nephritis and the effects of rituximab in lupus nephritis Class III and IV, it is reasonable to postulate that anti-CD 20 therapy with rituximab will also be effective in patients with membranous LN.

Who is Eligible to Participate in the Study?

• Age >18 years


• Diagnosis of SLE per current ACR classification criteria (at least 4 of 11 criteria)


• Kidney biopsy within 12 months of enrollment with membranous Lupus Nephritis (ISN/RPS V)


• Proteinuria >2 g/24h


• Full dose ACE inhibition (or ARB) for a minimum of 8 weeks at day 0. Patients may be on less than full dose due to lack of tolerability


• Stable corticosteroid dose in the 4 weeks prior to screening (including no corticosteroid)

Minimum Age:

18

Maximum Age:

70

What is Involved With this Study?

Screening
You will have a physical examination and routine blood and urine tests to determine if you are eligible to take part in the study. You will need to be on an angiotensin-converting enzyme (ACE) inhibitor for a minimum of 8 weeks and be taking corticosteroids prior to screening.

Treatment
At your Days 1, 8, 15, and 22 visits, you will have blood drawn for routine blood tests. The drug rituximab will be administered intravenously (directly into the blood by inserting a needle into your arm and allowing the drug to slowly enter your body over a period of time). During the infusions, you will have your vital signs checked periodically. Before the drug infusion, you will receive prophylactic (preventative) treatment to avoid an infusion reaction with acetaminophen (such as Tylenol) and diphenhydramine (such as Benadryl) and will receive IV methylprednisolone (steroids).

Follow-up
After the four infusions, you will have 12 monthly visits for routine blood and urine tests along with physical examinations by the study doctor. These visits will help your study doctor determine how you are doing and if the study drug may be changing your health status.

How long will the Study run?

The study procedures will last about 12 months. If your B-cell levels have not returned to normal or your baseline level at your 12-month visit, you will continue to be followed until they have returned to these levels.

Who can I Contact for Additional Information on this Trial?

Lori Riess
Phone: (507) 266-1047
Email: riess.lori@mayo.edu

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 11/05/2008