Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy

Description

Study Description:

Subjects with idiopathic membranous nephropathy will be treated with a combination of rituximab and cyclosporine. The study hypothesis of combining Rituximab and cyclosporine provides more effective immunosuppression than either agent alone by targeting both arms of the immune system which are believed to be involved in the pathogenesis of MN. The combination of Rituximab and cyclosporine may achieve greater reductions in proteinuria, increase the number of remissions (especially complete) of the nephrotic syndrome, decrease the number of relapses and perhaps reset the immune system, thereby obviating the need for long term immunosuppression. The prolonged effects of Rituximab on the immune system may allow for withdrawal of cyclosporine. Although each of these medications has been used separately in membranous nephropathy, the potential benefits and risks of this combination have not yet been formally explored.

Objectives:

Primary objective:

To determine the safety and effectiveness of combining rituximab and cyclosporine to treat membranous nephropathy by evaluating the acceptable safety profile and efficacy to reduce proteinuria.

Secondary objective:

To evaluate the efficacy to maintain durable remission.

Endpoints:

Primary endpoint:

Incidence of adverse events (AEs) will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE).

Number of subjects who achieve complete remission (CR), partial remission (PR) at 6, 12, and 18 months.

Secondary endpoint:

1. Time to remission
2. Time to relapse (in those who achieved a remission)
3. Change in proteinuria from baseline to 12 months