IRB Number:

07-001944

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

This research study will investigate the safety and efficacy of Rituximab in the treatment of IgA Nephropathy and compare it to patients treated with conventional therapy. Its primary purpose is to establish the effect of Rituximab on proteinuria and preservation of renal function in patients with IgA nephropathy. Our preliminary experience with Rituximab in IgA nephropathy indicates that approximately 80% of patients achieved a complete or partial remission.

Who is Eligible to Participate in the Study?

- Renal biopsy diagnosis of IgA nephropathy
- Age >18 years
- Proteinuria >1000 mg/24h without ACEi/ARB therapy; >500 mg/24h on ACEi /ARB therapy
- Adequately controlled blood pressure <130/80 mm Hg.
- Negative serum pregnancy test
- Patients with biopsy proven IgA nephropathy and clinical features consistent with Henoch Schonlein Purpura will be considered eligible for the study
- Estimated GFR<90 ml/min but >30ml/min/1.73m2

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 excrete greater than or equal to 1000 mg of protein in a 24-hour urine collection while on stable ACE or ARB therapy for 2 months. Patients receiving combination ACE or ARB will only require 500mg/24 hours for study eligibility.

Treatment
Patients will be randomized to either treatment with rituximab plus conventional therapy (Group 1) or conventional therapy alone (Group 2) and will be followed for 12 months after enrollment. If you are randomized into the rituximab group at your Days 1, 15, 168, and 182 visits, you will have blood drawn for routine blood tests and will received an intravenous infusion of rituximab.

How long will the Study run?

The study procedures will last about 12 months.

Who can I Contact for Additional Information on this Trial?

Shirley Jennison
Phone: (507) 255-0231
Email: jennison.shirley@mayo.edu

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 12/29/2008